Medical Plastics Data Service Magazine March - April 2020 by Medical Plastics Data Service

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The Importance Of Medical Device Packaging Pharmaceutical and medical device packaging must meet strict specifications to ensure patient safety. Salient Aspects Of Medical Device Packaging - Dr R Rangaprasad , Business Head, Packaging 360 , Mumbai Medical device Packaging doesn’t just need to arrive at the hospital, clinic, or end customer free of holes, tears or missing seals , it must also withstand the passage of time in storage , where it must be able to remain for years without…… Quality Management Of Packaging Materials For Medicines and Medical Devices - Dr K Sivakumar , Managing Director, Pharmedices Technical Services, Banglore The Quality Management Systems appropriate for packaging materials is ISO 9001- Quality Management Systems – Requirements, Interface with ISO 13485 , requirements for regulatory purposes and in addition for……. Looking For Contract Ethylene Oxide Sterilisation Facility ? - Bansi Dhurandhar , Director, Microtol Sterilisation Services Pvt Ltd, Mumbai Many manufacturers select a good contract sterilization service which turns out to be economical and convenient in the long run. The choice of the appropriate contract facility thus becomes the next important step. Why Anticounterfeit Packing for Medical Devices ? - Bhupesh Sood, Business Head, SECGLOBAL, Ahmedabad “WHO” defines counterfeit as medicine which is deliberately and fraudulently mislabeled with respect toidentify and / or source.Counterfeiting can apply to both branded and generic products and may include ………

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GLOBAL TRENDS COVID-19 and The Critical Role Of MedTech MedTech is playing a crucial role in ensuring that the right technologies are available.

• Labeling Requirements – Compliance to Law • ANNEXURE – II CHAPTER VI (MDR 2017) LABELLING OF MEDICAL DEVICES • AiMeD Welcomes Govt’s Schemes For Promotion Of The Domestic Manufacturing Of Medical Devices

• NPPA Notifies All Medical Devices As Drugs Under DPCO-2013 For Quality Control & Price Monitoring • Govt Announces Rs. 13,760-cr Package To Boost API & Medical Device Production In India, Industry Cheers Up • Cabinet Approves Promoting Domestic Manufacturing Of Medical Devices

• Single-Use Bioprocessing Components • Components To Reduce Critical Enteral Misconnections

• About Anti-Counterfeiting Packaging Technology for Medical Devices

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Mar. 2014 to Aug. 2014 • Cover Story : Advances In Sterile Medical Device Manufacturing (March - April 2014) - Prof. Sujoy K. Guha, School Of Medical Science And Technology, IIT, Kharagpur • Cover Story : Biocompatibility Testing Of Medical Devices: The Manufacturer’s Perspective (March - April 2014) - Dr. S. S. Murugan, Managing Director, GLR Laboratories Pvt Ltd, Chennai And - Dr. T. S. Kumaravel, Founding Chairman, GLR Laboratories Pvt Ltd.,Chennai • Cover Story : Packaging Testing For Medical Devices (March - April 2014) - Divya Ganapathy, Technical Consultant – Medical Device Regulatory Services, UL India Pvt. Ltd., Bangalore • Global Trends : Singapore: Medtech Companies’ Strategic Base In Asia (March - April 2014) • Did You Know : About What Global Medtech Manufacturers Need To Copy From India and China (March - April 2014) • Cover Story : Medical Device Industry : Contract Manufacturing For Smarter, More Cost-Effective Production (May - June 2014) • Cover Story : Development Of Plastics Injection Molded Medical Device : A Systematic Approach Is Key To Success (May - June 2014) - Mr. Nikhil Patel, Director, Credence Management Corporation, Vadodara • Cover Story : Regulatory Issues In Contract Manufacturing (Out Sourcing) Of Medical Devices (May - June 2014) - Mr. Sanjay Shah, CEO, Unikal Consultants, Ahmedabad • Global Trends : Global Medical Device Outsourcing Market will Grow to Over $12 Billion by 2018 (May - June 2014) • Global Trends : Trends Favor Growth For Plastics In Medical Market (May - June 2014) • Did You Know : About When to consider outsourcing Medical Device Manufacturing to a contract manufacturer ? (May - June 2014) • Cover Story : Medical Device Sterilisation: Key Essentials, Options And Challenges (July - August 2014) • Cover Story : Importance Of Sterilisation (July - August 2014) - Ms. Divya Ganapathy, Technical ConsultantMedical Device Regulatory Services, UL India - Mr. Jan Peeters, Global Program Manager, Scientific Director & Primary Designated Engineer (PDE), UL Germany...

About Anti-Counterfeiting Packaging Technology for Medical Devices Counterfeit products are those which are fake, or those which have been deliberately mislabeled or tampered with - Not same as sub-standard devices, which have failed quality control checks. In 2010, WHO reported that 8% of all medical devices in circulation are fake, with actual numbers expected to be even higher. They have significant impact on the health of the users. Counterfeit devices are a threat to the society and there is an urgent need to detect such devices. Detecting counterfeit devices is challenging : Firstly, many anticounterfeiting devices do not function properly in tropical climates. Also, it is difficult to determine if the poor performance of a device is due to poor quality or poor practice. Poor lab practices, inadequate training, or an inability to interpret results can lead to investigators falsely believing that the device is counterfeit. Anti-counterfeit packaging : Protecting the authenticity of a device through anti-counterfeit technology is one of the ways through which companies detect fake products. Nano/microparticles : One of the methods against counterfeiting involves incorporation of dust-sized or micro particles in to the packaging, labels, or the device itself. These particles are made of silicon dioxide, and they can carry digital information which can be used to identify, trace, and authenticate products for product identification. These particles are incorporated covertly such that the packaging is not affected. These particles can also be incorporated using pre-existing laminates and varnishes. SignatureDNA : Another anti-counterfeit method creates unique identification marker using DNA called ‘SignatureDNA’ technology where specific DNA signatures can be incorporated in to packaging and the material itself. It works as a “lock and key” model where the DNA in the package/material can only be unlocked using its complimentary DNA pattern. Tamper-evident opening system or TOES : Which contains a peelable cover foil in the packaging. Cover is destroyed if the packing is tampered, and this can provide protection if the package is illegally opened or misused. https://www.news-medical.net/life-sciences/Anti-counterfeiting-Technologyfor-Medical-Devices.aspx

"I cannot teach anybody anything, I can only make them think." - Socrates

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D.L.PANDYA, B.E.(Chem), M.I.E.

EDITORIAL ADVISORY BOARD

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Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai Mr. ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 • Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

COVID-19 is Changing the face of Healthcare at an Unprecedented Pace including the Importance Of Medical Packaging. The MedTech industry is in the frontline playing a crucial role in ensuring that the right technologies are available, at scale and speed, for healthcare providers and patients to combat the Virus. In this new scenario , Medical Packaging being one of the most significant element in the development and manufacturing of Medical Devices, companies have to face new set of challenges. The medical device development is not limited to the devices themselves, but also extends to their packaging and labelling. In a study carried out by a leading packaging material company, it was found that 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging. Looking to such importance, this issue of “Medical Plastics Data Service” focuses on five very important and very well researched articles by leading Industry professionals. They represent medical device industry disciplines including Manufacturing, Quality Control & Management, Packaging as well as Regulatory Requirements. An article on “Salient Aspects Of Medical Device Packaging” by Dr. R. Rangaprasad, Business Head, Packaging 360 covers all important aspects including development of packaging, design considerations, standards as well as testing processes. Dr K. Sivakumar, Managing Director, Pharmedices Technical Services has in his article on, “Quality Management Of Packaging Materials For Pharmaceuticals And Medical Devices” very elaborately given an overview on Quality Management Systems, its implementation and requirements for effective implementation of Quality Management Standards including ISO 13485 for Medical Device Packaging Materials. One more important aspect covered is about Medical Device Sterilisation. Mr Bansi Dhurandhar, Director, MICROTOL Sterilisation Services Pvt Ltd” has given very detailed explanation on “How to Select Contract Ethylene Oxide Sterilisation Facility" for those manufacturers who are looking for this service. “WHO” has reported that significant number of Medical Devices circulated globally are fake with significant impact on the health of users. Mr Bhupesh Sood, Business Head, SECGLOBAL explains the “Importance of Anticounterfeit Packing For Medical Devices”. Various Anti-Counterfeiting Packaging Technologies For Medical Devices "are also highlighted in the “Did You Know Column” in this issue. One more issue related to “Labelling Requirements with respect to Compliance to Law" are covered in our regular "Regulatory Updates" column . We hope, all these, along with our other regular features like Industry News, Product Gallery, Events etc. will be of great informatory value to the readers.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

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The Importance Of Medical Device Packaging As per “Data Bridge Market Research “ , Global Medical Device Packaging Market is expected to rise from its initial estimated value of USD 27.25 billion in 2018 to a projected value of USD 43.99 billion by 2026, registering a CAGR of 6.17% in the forecast period of 2019-2026. Asia Pacific Medical Device Packaging Market is expected to reach USD 8,892.6 million by 2024, from USD 5,054.4 million in 2016 growing at a CAGR of 7.4% in the forecast period 2017 to 2024. This rise in market value can be attributed to innovations in packaging products offering and services. The medical device development is not limited to the devices themselves, but also extends to their packaging and labeling. While medical devices are developed under rigorous quality controls, packages that house them are also subjected to rigorous validation processes. The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. The resilient packaging must also meet rigorous labeling standards to meet regulatory requirements. Regulations do not just ensure monitoring and controlling of device quality, it also ensures that the packaging used is safe and effective at keeping the contents clean and germfree. In a study carries out by a leading packaging material company , it was found that 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging. Pharmaceutical and medical device packaging must meet strict specifications to ensure patient safety. After specification development, medical packaging is subjected to rigorous testing procedures during which precise requirements and

specifications can be tested and confirmed, or, if needed, rejected and redeveloped. In most cases, packages are intended to simply contain the product. However, for medical devices, there are other functions that the package serves; it provides protection, identification, processability, ease of use, and special applications for device use and presentation. A basic knowledge of the product's use, dimensions, shape, and special characteristics (e.g. sharp edges, points, fragility, etc.); distribution environment, application, and barrier requirements are essential to selecting appropriate materials and effectively designing the final package.

A sterile medical device must have : • Sterilization: Provide the ability to terminally sterilize the d e v i c e by one or more methods without degrading the material. • Shelf Life: Ensure the stability of the material as a barrier throughout the life cycle of the product. • Environmental: Barrier to moisture, air, bacteria, oxygen, light. • Physical: Provide dynamic protection, resist impacts and abrasion, and offer structural support. Looking to the importance of the subject , the cover story highlights following important aspects regarding Medical Device Packaging : • Salient Aspects Of Medical Device Packaging • Quality Management Of Packaging Materials For Pharmaceuticals and Medical Devices • Selecting the right Contract Ethylene Oxide Sterilisation Facility • Anti-Counterfeiting Packaging Technology For Medical Devices.

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Salient Aspects of Medical Device Packaging

Dr. R. Rangaprasad Business Head, Packaging 360

Definition of a Medical Device The Global Harmonization Task Force (GHTF) has proposed the following harmonized definition of a medical device: Any instrument, apparatus, implement, machine, appliance, implant in vitro reagent or calibrator, software, material, or other similar or related article. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of : • Diagnosis, prevention, monitoring, treatment, or alleviation of disease. • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury. • Investigation, replacement, modification, or support of the anatomy or of a physiological process. • Supporting or sustaining life. • Control of contraception. • Disinfection of medical devices. • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and B. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means. By definition, devices are involved in many different aspects of healthcare. As such, devices, their manufacturing processes, and the packaging that contains and protects them are extremely disparate. Complicated capital equipment, such as MRI tunnels and X-ray machines, are medical devices, but so are simple, commodity-like items such as tongue depressors and syringes. Some are meant for mass markets; others are niche items. Some are packaged individually; others are packaged in boxes of 100 s or 1000 s. Some are reprocessed, others are disposable, and some are used for a lifetime. Risks associated with device misuse and failures are equally varied, ranging from inconvenience to patient death.

Classification of Medical Devices The great variation present in the medical device industry means that devices can be classified in a number of ways. Devices can be categorized by : • The risk associated with improper use or a failure (generally high, moderate, and low). • Conditions of processing (reusable, disposable, capital equipment, etc.). • Conditions of the therapy (invasive, noninvasive). • Conditions of shipping and handling (capital equipment, commodity surgical, etc.).

Because the goal of these therapies is to maximize efficacy and protect patient safety, the most common way to classify devices is based on risk. Key Considerations for The Development of Medical Device Packaging. In addition to the normal functions of a packaging system, the following requirements are unique to Medical Devices.

Sterile Barrier System The vital importance of maintenance of the sterile barrier system (SBS) is a distinctive characteristic of medical device packaging. Medical device packaging for disposables must not only maintain the SBS but, in many cases, also facilitate the sterilization of the device within. Such protective characteristics can be achieved through the package shape, particularly in thermoformed parts, in order to avoid product shifting or to keep kit components separated or nested. For sealed packages, seal integrity is an important characteristic in product protection. Seals must be free of channels and must withstand the rigors of sterilization and transit.

Utility Utility is related to the ease of use of the system. For many medical devices, quick and easy opening and removal of contents are crucial. While this consideration is also important for devices with relatively low risk, such as an adhesive bandage, it is extremely critical for sterile medical devices that are used in surgical arenas where the packaging must allow the device to be removed without contamination. This particular need has led to the development of special materials and sealants that, when used in combination, can provide package strengths that are adequate to endure the severity of processing and, at the same time, can be manually opened without imposing excessive stress on product or user.

Communication As with consumer goods packaging, secondary and primary medical device packages are a means to convey information through graphics, materials, and shape. Packaging communication operates at different levels, depending on the type of medical device. For over-the-counter (OTC) medical devices, such as condoms, glucose meters, adhesive bandages, thermometers, and so on, the communication role involves motivating a purchase, as well communicating important information for the safe and effective use of the medical device. Information may include directions, warnings, product benefits, brand differentiation, and so on. A very important aspect of package communication is product identification. This is especially true for devices that go into

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institutional settings, such as hospitals, where personnel may have to identify the correct device for a patient when seconds count.

Key Package Design Considerations During the early design stages, it is critical to define the following parameters: • Critical product characteristics. • Type(s) of protection required (physical, ultraviolet light, O2, water vapor transmission, etc.). • Type of sterilization process. • Where and how the product is going to be dispensed (OTC, surgery, etc.).

Medical Device Packaging Requirements Complying with packaging requirements is the responsibility of the medical device manufacturer. This is the only way to guarantee that the products will be protected during transportation, and that they comply with health and safety regulations. Pharmaceutical and medical products have certain special characteristics (such as their limited shelf life). For this reason, their requirements for transportation and commercialization must be aligned with them. The protocols aimed at guaranteeing their safety focus on factors such as the seal integrity, materials or how the package reacts to the passage of time. At a government level, the most important regulations are those of t h e F o o d & D r u g Administration (FDA) in the United States, and the Medical Devices Directive in the European Union. Medical device packaging doesn’t just need to arrive at the hospital, clinic, or end customer free from holes, tears or missing seals; it must also withstand the passage of time in storage, where it must be able to remain for years without the drug or device having their composition altered. Some of the medical device packaging protocols include : • ISO 11607 Packaging for terminally sterilized medical devices. • ISO TS 16775, “Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2.” • EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods. • ASTM D1585 Guide for Integrity Testing of Porous Medical Packages. • ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. • ASTM F3475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. • BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). • ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market.

• ISO 11137, which measures Gamma and E-beam sterilization. Before performing any of these tests, one must ensure that the package is sterile, so that protocols are performed on a product that is exactly in the same condition as that of the product to be commercialized.

Notable changes to ISO medical packaging standards Updates to ISO 11607 and ISO TS 16775, standards covering packaging for terminally sterilized medical devices, may help manufacturers comply with EU Medical Device Regulation set to go into effect next year. With an application date of May 2020, the new EU Medical Device Regulation (MDR) is fast coming —a daunting prospect for medical device manufacturers. But updates (one published and one still undergoing revisions) to two standards covering packaging for terminally sterilized medical devices could help prepare the industry for compliance with the new European rules. Revisions to ISO 11607-1/2 and ISO TS 16775 were written to harmonize with the General Safety and Performance Require-ments (GSPR) contained in the EU MDR. A provision in ISO 11607-1:2019, “ P a c k a g i n g f o r Te r m i n a l l y Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems,” directs packagers to complete a documented usability evaluation for aseptic presentation in either a real or simulated-use environment. That requirement is in line with the EU MDR directive that medical device manufacturers find ways to improve usability in case of unfavorable post-market surveillance feedback from end users. Other notable changes in ISO 11607-1/2:2019 “Sterilization of Health Care Products—Packaging,” include the following: • Formal inclusion of risk management. • A new annex on ways to differentiate a sterile barrier system from protective packaging. • A new section on visual inspection. • A section on design changes and validation. • A revised section on process validation that includes the new concept of a process specification. • A new annex on environmental aspects according to ISO and CEN guidance. The EN ISO versions have not yet been published, but Wagner said the EU committee in charge of EN ISO 11607 was set to meet with a consultant last month to work on harmonization with the EU MDR. Also still under revision is ISO TS 16775, “Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2.” A new effort is seeking to develop a symbol to enable users of sterile packaging to distinguish a sterile barrier system from a protective layer and help packagers comply with the EU MDR Annex I Section 23.3, which requires indication of a sterile barrier.

Testing processes for medical packaging design Protocol ISO 11607 outlines the key aspects of pharma and medical device package testing. Mar.-Apr. 2020

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On one hand, it describes the key aspects of testing medical device packaging, including the classification of the material, testing the sealing process and the integrity of the seals of the entire package. On the other, it includes the physical tests to be performed, which include burst, deformation, strain to failure, detachment and leak testing. Finally, transport simulations are also required, so as to test the package’s resistance and ability to protect the goods from the hazards of the distribution cycle. In summary, transport testing involves three types of tests: 1. ISTA 1 Series. Integrity performance tests without simulation to test the resistance and strength of the product-packaging combination. 2. ISTA 2 and 3 Series, as well as ASTM D 4169. These involve general simulation performance tests via simulation designed to mimic the conditions that may be experienced during the shipping process. These include: • Environmental conditions. • Random vibration through the use of vibration equipment. • Drop Tests from different heights. 3. A third type of personalized test, depending on the character-

istics of the product itself and the real distribution cycle to be endured by the product. In this case, it is common to use recording devices such as a Data Recorder, which provide real information regarding transportation conditions. In addition to the tests mentioned above, other types of simulations can be performed, including: • Compression tests using simulation equipment to measure the resistance of a package to compression forces. • Rotational impact and drop tests in simulation systems to measure the protective capabilities of the package in a laboratory setting. All of the aforementioned requirements must be taken into account when deciding on the medical packaging design. These processes are aimed at detecting potential risks linked to the distribution cycle with the purpose of redesigning or optimizing the package. This leads to a higher safety for the goods and a reduction in costs associated with damages during transportation. References: 1. The Wiley Encyclopedia of Packaging 2. www.safeloadtesting.com 3. www.packagingdigest.com

Dr. R. Rangaprasad is a polymer & packaging professional with over 25 years’ experience . At present He is Business Head at Packaging 360, A comprehensive knowledge service provider platform., involved in Training, Consultancy & conferences. He has served as Consultant at Indian Institute of Packaging Mumbai & as Director at SIES School of Packaging / Packaging Technology Centre, Navi Mumbai. Dr. R. Rangaprasad. is a chemical technologist by training, from the prestigious UICT, Mumbai and holds B.Sc (Chemistry), B.Sc (Tech.), M.Sc.(Tech) & Ph.D.(Tech). Degrees. After obtaining his doctorate degree, He began his career in the R&D department of Polyolefins Industries Limited (PIL), in 1992. During the three year stint, he worked on stabilization protocol of polyolefins, notably, HMHDPE & EVA copolymer. He also gained expertise in the application areas of HMHDPE related to packaging films, raffia tapes, and pipes. He also setup the compounding project of PIL’s filled & reinforced polypropylene at R&D & was responsible for scale-up & market development of mineral –filled PP & PE & glass reinforced PP for various end-use sectors. Between 1995 & 2007, He was associated with Product Application & Research Center of Reliance Industries Limited (RIL), where he gained expertise in stabilization of polyolefins; PE &PP, compounding and masterbatches for various end-use sectors. He was actively involved in developing applications in various end use segments such as automotive, appliances, medical, wire and cables, packaging, infrastructure etc. During this tenure, he published over 100 technical papers in journals, participated in national & international conferences, contributed chapters to books & was also involved in evolving knowledge management & training programme for polymer business for cross- functional groups. Dr. R. Rangaprasad has served as visiting faculty from industry at UICT, Mumbai; Amrita Vishwavidyapeetam, Coimbatore, Nirma Institute. He was honored as UDCT –IPI Diamond Jubilee Visiting Professor in Polymer Processing. He has also conducted training & knowledge workshops at leading FMCG companies in the area of design of polyolefin materials for packaging sector.

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Quality Management of Packaging Materials for Medicines and Medical Devices Dr. K. Sivakumar M. Pharm, Ph.D Managing Director, Pharmedices Technical Services

Classification And Types Of Packaging Materials, Quality Management Requirements, Implementation Of Quality Management System In Compliance With Requirements Of ISO 9001, Interface With Quality Management Systems – ISO 13485, Special Quality Management Standards, Quality Management System For Primary Packaging Materials , Requirements And Implementation Of Quality Management Standards

Introduction : Medical Devices are important components in healthcare together with medicines, medical care, nursing care and public health programmes. The quality management of medicines and medical devices are regulated by healthcare regulations. In India, the regulations governing the Quality Management of Medicines and Medical Devices by Central Drugs Standards and Control Organization are through Indian Drugs Cosmetics and Medical Devices Act and Rules. The International Standards applicable for Quality Management of medical devices are ISO 13485 and the associated standards such as ISO 14971 on Risk Management, ISO 10993 on Biocompatibility evaluations, ISO 14155 on Clinical Evaluations. There are other international standards which are applicable depending on nature of medical devices. The regulations in other regional and national health care administrations are European Medical Device Regulations, Quality systems Regulations of USA, Medical Devices Regulations of Canada etc. Packaging materials are integral part of medical devices and medicines, which are packed in them. The packaging materials are quite a constituent part of ensuring the efficacy, safety and reliability of medicines and medical devices. The packaging materials serve as containers and closures for the medicine and medical devices, offer protection from mechanical damage, environmental factors and ensure stability of the medicine and medical devices contained in them. Therefore, it is important that the packaging materials are designed, manufactured and supplied to manufacturers of medicines and medical devices according to well established quality management systems and medicines and medical devices are packed in them and processed as per the requirements. In this article, an overview of the Quality Management Systems applicable for packaging materials are described.

Classification and types of packaging materials The packaging materials are made of a variety of materials, such as glass, plastics, paper, laminates, rubber, other polymers and composite materials. From the perspective of Quality Management Systems, the packaging materials could be classified as primary, secondary and tertiary packaging materials. The primary packaging materials are those which are in direct contact with the medical device or medicine contained in

them. Examples of primary packaging materials are: containers such as plastic containers, bottles, vials, ampuls, aluminium foils, foil laminates, paper laminates, plastic laminates, pouches etc. When bottles or vials are used, the corresponding closure systems also form the primary packing materials. They perform the functions of being the containers for the medicines and medical devices, ensuring ease of administration as per therapeutic indication, facilitating handling and distribution of the contents in such way that the contents are protected from environmental factors, contamination including chemical, particulate and biological contaminants, and ensuring stability of the contents. The labelling information as per the regulatory requirements are either printed or affixed as label on the primary packing materials. It is important that the material and design of primary packing materials are compatible with the product contained in them, with respect to physical, chemical and sterility requirements of the products. They should be tamper proof and provide adequate protection against misuse of and damage to the contents. The secondary packaging materials are those in which the medicines and medical devices in their primary pack are assembled in number of units appropriate for handling, storage and distribution to wholesale, retail and individual users and customers. They should have appropriate labeling information either printed or affixed on them. They could be made of cardboard and fibreboard, plastic containers or corrugated boxes. The tertiary packaging materials are those in which the secondary packs are assembled and shipped to destinations for further distribution in supply chain. They are usually made of corrugated boxes.

Quality Management requirements for packaging materials: The Quality Management packaging materials is interrelated to the quality management systems of medical devices and medicines which are contained in them. The quality management systems appropriate for packaging materials is ISO 9001 -Quality management systems — Requirements, interface with ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes and in addition, for primary packaging materials ISO 15378 Primary packaging materials for medicinal products — Particular Mar.-Apr. 2020

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requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). In the following sections of this article, essential principles of the above standards are described. Implementation of Quality Management System in compliance with the requirements of ISO 9001: The manufacturers of packaging materials are well recommended to have a quality management system in compliance with the requirements of ISO 9001: 2015. Though the compliance with the requirements of ISO 9001 is a voluntary standard, most of the manufacturers of medicines and medical devices expect the suppliers of packaging materials to implement a QMS in compliance with the requirements of ISO 9001. The compliance is verified by the manufacturers of medicines and medical devices by conducting audits of the manufacturer of packaging materials and or requiring the compliance to ISO 9001 be demonstrated by certification by a certification body. It is important that the certifying body be accredited to a national accreditation body, because the certification by unaccredited body is not of any recognition and does not add value to business by the manufacturer of packaging materials. The requirements of ISO 9001 are based on ‘PDCA’ approach – Plan, Do. Check and Act. The requirements are grouped on the basis that the manufacturer of packaging materials should have an organization to comply with the requirements of Quality Management, with commitment of top management. A clear quality Policy should be defined by the top management and communicated to all the personnel in the organization. Required resources in terms of production facility, quality systems, personnel, documentation, infrastructure should be provided by the top management. The customer focus is kept at the centre and all the support for planning and achieving quality objectives should be provided. The quality objectives and operational parameters should be measurable and the top management should provide adequate resources for measuring and monitoring the required parameters. The efficacy of the implementation of QMs should be reviewed by the top manage-ment at periodic intervals. The essential requirements of ISO 9001 are: • Understanding the needs and expectations of interested parties, • Determining the scope of the quality management System • Quality management system and its processes • 5 Leadership • 5.1 Leadership and commitment • 5.1.2 Customer focus • 5.2 Policy • 6 Planning • 6.1 Action to address risks and opportunities • 6.2 Quality objectives and planning to achieve them • 6.3 Planning of changes • 7 Support • 7.1 Resources • 7.1.2 People • 7.1.3 Infrastructure • 7.1.4 Environment for the operation of processes • 7.1.5 Monitoring and measuring resources

• • • • • • • • • • • • • • • • • • • • • • • •

7.1.5.2 Measurement traceability 7.1.6 Organization knowledge 7.2 Competence 7.3 Awareness 7.4 communication 7.5 Documented information 8. Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of the requirements for products and services 8.2.4 Changes to requirements for products and service 8.3 Design and development of products and services 8.4 Control of externally provided, products and services 8.5 Production and service provision 9 Performance evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.2 Nonconformity and corrective action 10.3 Continual improvement

The compliance to ISO 9001 emphasises estimation of risks of failures and appropriate corrective and preventive actions are taken in time so that products are safe and nonconformances are minimised and quality objectives are achieved.

Interface with Quality Management Systems – ISO 13485 ISO 13485 is quality management standard for medical devices. The interface of quality management system with that of the manufacturers of the medical devices is highlighted in the following sections: 7.3 Design and development: The design and development of medical devices include designing , selection, development and use of appropriate packaging materials which will enable the design inputs and design outputs of medical devices are met to ensure the performance, efficacy, safety and reliability of medical devices. 7.4 Purchasing: This section outlines the requirements that the manufacturer of medical device shall comply with, to ensure the quality requirements of medical device. It is required that the medical devices manufacturer shall establish clear specification for the raw materials and packaging materials used in their product; shall procure materials only from approved suppliers; the supplied materials shall meet the requirements specified by the manufacturer of medical device; the performance of the suppliers of materials shall be evaluated on a periodic basis including vendor audits. Hence, it is important that the manufacturers of packaging materials should comply with quality management systems and supply materials of consistent quality to the manufacturers of medical devices. The medical device manufacturers are required to clearly specify the quality specifications of packaging materials and the manufacturers of packaging materials should comply with them. The conformance

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to the specifications shall be verified by the manufacturers of medical devices. 7.5.9 Traceability: It is the requirement that the manufacturers of medical devices establish and implement procedures for traceability of devices manufactured and the components used in them, including packaging materials. Therefore, the requirement of traceability is established in manufacture of packaging materials as well, so that the same could be linked to the traceability of medical devices. In addition, the sections on labelling, control of nonconformance, measurement, internal audit and improvement also have impact on the quality of packaging materials and the manufacturers of packaging materials.

Special quality management standards for packaging materials. In addition to the general quality management standards described as above, there are specific quality management standards for primary packaging materials and packaging materials for sterile medical devices.

The quality management system for primary packaging materials The quality management system for primary packaging materials is given in ISO 15378. ISO 15378 is a special standard for application of ISO 9001 and principles of Good Manufacturing Practices. The primary packaging materials are those which come in direct contact with the medicines and medical devices and include the primary container and closure systems. The essential requirements of ISO 15378 are derived considering the principle that the primary packaging material should be manufactured with compliance to quality requirements similar to that of medicines and medical devices. It is an international standard comprehensively addressing the principles of Good Manufacturing Practices, Quality Management Systems for medical devices, Risk Management and requirements for sterile medicinal products. It underpins the relationship between the manufacturer of packaging materials and manufacturer of medicinal products as operating on a technical agreement for overall compliance of medicinal products to quality specifications.

packaging materials and while during supplier evaluation and vendor audits. Hence, the manufacturers of primary packaging materials are recommended to implement the quality management system and get it certified by any accredited certifying body.

Packaging materials for sterile products The quality requirements of selection and use of appropriate packaging materials for sterile medicals are given ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Requirements and implementation of quality management Standards for packaging materials The details of the requirements of the standards outlined above and guidelines for implementation of such quality management systems will be described in the subsequent parts of the series of articles on this subject, to be published in the future editions of this publication.

References: i) ISO 9001 -Quality management systems —Requirements, ii) ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes iii) ISO 15378- Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). iv) ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.

The essential principles of ISO 15378 are: • 4.1.1 Risk management • 6.2.2.1 GMP training • 6.3 Infrastructure • 6.4.1 Work environment requirements • 7.3.7.1 Notification • 7.3.7.2 Design change • 7.5.1.1 Cleanliness of product and contamination control • 7.5.1.2 Segregation controls • 7.5.1.3 Change control • 7.5.1.4 Particular requirements for sterile primary packaging materials • 7.5.3 Identification and traceability • 8.2.4.1 Investigation of OOS results (Out Of Specification) • 8.2.4.4 Batch release • 8.2.4.5 Retained samples • 8.2.4.6 Production and control data ISO 15378 also has annexes describing the requirements of printed primary packaging materials, validation and risk management. The compliance to the requirements of ISO 15378 is currently voluntary. However, many leading manufacturers of pharmaceuticals and medical devices, use the requirements of this standard in their technical agreements with the suppliers of

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Looking For Contract Ethylene Oxide Sterilisation Facility ?

Bansi Dhurandhar Director MICROTROL Sterilisation Services Pvt. Ltd. Terminal sterilisation is the most important step in manufacturing of sterile medical devices. Extensive use of plastics and polymers as material for construction has necessitated conducting sterilisation at lower temperature. The most common methods are fumigation with Ethylene oxide gas and Ionization radiation using Gamma irradiation or Electron beam. Ethylene oxide sterilisation is by far the most popular and convenient method of sterilisation for most medical devices. It is believed that more than 60%of medical devices the world over are sterilised by Ethylene oxide gas. Though the process seems to be simple, compliance to various quality standards, reliable automation, safety requirements and environmental issues etc. have made this popular technique face frequent upgradation. For manufacturers of medical devices therefore, it becomes an extremely important decision either to have in-house sterilisation facility or rely on contract service providers.

Hence, many manufacturers select a good contract sterilisation service which turns out to be economical and convenient in the long run. The choice of the appropriate contract facility thus becomes the next important step.

Equipment : A Contract facility should have the latest equipment. The “EtO Steriliser” has undergone severe technological advances over the years. While the equipment should qualify and meet quality requirement, it should also ensure intrinsic safety by virtue of selection of material of construction, appropriate accessories and state of the art instrumentation.

In earlier days, making a choice between contract service provider and in-house facilities was based purely on economic considerations. If the volume of devices produced per day requiring sterilisation justified investment and running cost; an inhouse facility was the answer. The small manufacturer could not establish in-house sterilisation facilities as Capex was relatively high. Therefore, they would patronise a contract facility. Large manufacturers too relied on contract facilities as their production volume necessitated sufficiently large Sterilisation capacities which was akin to running a separate activity with dedicated personnel and also resulting in diverting attention away from their core business. However, a large number of medium scale manufacturers face a dilemma in taking a decision. Cost of primitive looking Sterilisation chamber made of Carbon steel and vacuum pump with basic instrumentation without automation can be installed at reasonable cost and running the same without regulatory measures appears to be an extremely attractive proposition. Further, it reduces transportation costs, making the decision to have in-house facility appear attractive. However, quality consciousness, compliance to various standards, meeting statutory requirements like Food & Drug Administration, Medical Devices Rules, Factory inspectorate, Pollution control, Labour laws and insurance are some aspects which need due attention. It is true that in addressing all these results in a drain on resources. Mar.-Apr. 2020 D A T A

Gone are the days, when an EtO Steriliser was just a metal box connected to a vacuum pump and cylinder containing an Ethylene oxide gas mixture. The equipment today needs to comply with DIN EN 1422 requirements and provision for additional ports to introduce sensors for validation. Controls should be fully automatic through PLC and must have a facility to continuously monitor pressure, temperature, humidity and time. All instrumentation must be of flame proof rating. It should meet the installation qualification criteria in terms of leak rates, temperature profile and loading configuration essential for theproduct to be sterilised. S E R V I C E

Process : Having identified a conveniently located contract facility and their capability in terms of adequate and appropriate equipment, the process of sterilisation becomes the next important aspect. Most contract facilities have pre-established standard procedures. It is important to ensure that these standard procedures do not physically affect the product or damage integrity of its packaging. Some polymers are known to develop deformities due to overexposure at later date. It of utmost importance to ensure that all gauges, instruments, sensors etc. are periodically calibrated by a qualified agency and their schedules are strictly observed.

Validation : Equipment qualification and process validation are just not buzz words but should be the password for a medical device manufacturer and the sterilisation services provider. Validation is in three parts: • Installation qualification • Operational qualification and • Performance qualification. The specification to which the steriliser is manufactured and respective compliance becomes part of installation qualification. Operational qualification is related to the performance of the equipment; this is normally done without the product Performance qualification is in two parts; this involves the actual product to be sterilised. • Performance qualification physical: where critical parameters like temperature profile, rate of evacuation and increase in pressure proportionate to quantity of gas, etc. are defined with repetitive trials. • Performance qualification microbial: is achieved by half-cycle qualification with sterility assurance level of 10-6, by using

biological indicators. The service provider must provide a validation protocol and carry out periodic process validation which is product specific.

Compliance to regulatory standards: Medical device manufacturing is a highly regulated process. ISO 13485-2016 is the standard for Quality management systems for medical devices while ISO 11135-2014 specifies requirements for sterilisation of health care products with Ethylene oxide. It should be mandatory for a quality medical device manufacturer to ensure that the contract sterilsation services provider has been audited and certified by a notified body to comply with the requirements of ISO-13485 and ISO-11135. There is one more facet that needs attention while selecting a qualified contract Sterilisation service provider. Ethylene oxide is very toxic and hence it is the responsibility, both, moral and societal of the service provider to ensure appropriate disposal of used Ethylene oxide gas. Catalytic converters, flare towers and abatement systems are some of the equipment which are used effectively. However, in reality to save money, many facilities do not install such equipment and release Ethylene oxide into the atmosphere instead. New regulations are being proposed to monitor and control EO levels in environment but it is the moral responsibility of the device manufacturer to ensure that their sterilisation contractors provide for EtO abatement systems that manifests that they are not only law abiding but socially conscious citizens. A contract sterilsation service provider, meeting all the above requirements is the answer for a quality Medical device manufacturer; after all, they deal with lifesaving devices and therefore need to ensure that the product being manufactured meets International standards and contributes to our Hon. Prime Minister, Narendra Modi’s ‘Make in India’ objective.

Bansi Dhurandhar is the pioneer of Ethylene oxide sterilisation in India. Working in the field of sterilisation for last 45 years, he has witnessed the medical device industry grow from it’s infant stage. He has been duly recognised by Intellectual property Organisation, Geneva for his work in the field of sterilisation for developing countries. He is Director of Microtrol Sterilsation Services Pvt. Ltd. which specialises in offering sterilisation services through it’s facilities spread all over the country. This includes EtO sterilsation, Gamma irradiation, Electron beam and Natural pasteurisation by steam.

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Why Anticounterfeit Packing for Medical Devices?

Bhupesh Sood Business Head, SECGLOBAL By Bhupesh Sood (MBA, WHO – AAR , Certified Six Sigma Green Belt, Data Science Foundation, MDR 2017, ISO 13485, ISO 9001, ISO 14001, ISO 45001, WCA) WHO defines Counterfeit as:A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of ingredient(s) or with fake packaging.It is widely accepted that counterfeiting medical devices is a threat to the patient safety. With regulators becoming more stringent, the requirements must be adhered to , to stay in business, for a longer duration. Universally, falsifying is thought to represent one to two percent of worldwide exchange. The secretive idea of forging makes it difficult to precisely measure the size of the fake clinical gadget issue in the United States. While some exploration shows that up to eight percent of clinical gadgets are fake all around, it is exceptionally improbable that the figure is that high inside the U.S. While exact estimation is difficult, the documented seizures statistics from the Department of Homeland Security, FDA recalls, and highly publicized counterfeit discoveries, nonetheless provide evidence of widespread counterfeit proliferation within the legitimate supply chain.Anticounterfeit measures secure both the maker and the end customer. A counterfeit medical device, when used, places the patient at serious risk and impacts the maker through potential loss of reputation, cost of removing these phony product out of the system and additional effort to prevent further issues occurring. Another major challenge is anti-diversion. This is to ensure that products that have been developed for a specific market, perhaps with materials that are not allowed in other countries but are authorized for the intended market, validated, compliant and fit for purpose, are not removed from the supply chain, repackaged and sent into a country that should not receive that item. It can be potentially dangerous for patients and is illegal. Therefore, the challenge is to avoid both counterfeit and diverted products.

Passive methods apply to the packaging. Medical devices have 3 levels of packaging: The primary packaging (pouch), which then goes into a secondary box (product box) and finally packaged into a shipper where there will be multiple products stored in one package To abstain from duplicating, producers can apply obstructions to every one of these things of bundling. Regardless of whether that be a 3D image, UV ID code, 2-D scanner tag with one of a kind numbering/serialization or shrouded content printed utilizing security or attractive ink. These are not planned as end-client checks yet as impediments to the forger. A prepared individual can rapidly build up if the item is bona fide and can take things further by referencing the one of a kind numbers utilized in the security checking through a confirmation site. A unique serial number or reference number (URN) is a randomized number printed onto the product’s packaging and as it’s unique, it can be used to define exactly who manufactured the item, where it was manufactured and the country of origin. This sort of serialization at the device level is crucial in the battle against forging. Serialization not just enables to confirm the item as authentic, yet additionally offers the capacity to follow item development all through the production network, improve effectiveness and in particular, secure the end client. Modern technologies can then use the serialized data in barcode format, which can be scanned at any point throughout the supply chain and checked with online systems to verify its authenticity. In the event that the look-into returns with no read/copy, at that point we know there is an issue with the device and it tends to be dismissed out of the production network and extra activity taken to expel these fake devices. These techniques unmistakably work, are basic and financially savvy to execute. Conclusion Organizations need to make sure that they put into practice the correct systems and processes that can support them in meeting global standards and country-specific requirements now and in the future. Implementing a fit-for-purpose validated labeling solution with in-built serialization capabilities, which can provide very high volumes of unique, secured and “intelligent” serial numbers for this process would therefore be vital.

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Reference. 1. Keeping up with Counterfeiters: The Battle Against Counterfeit Medical Devices By Steve Ellison , Steve Ellison, PRISYM ID (https://www.medtechintelligence.com/column/keeping-upwith-counterfeiters-the-battle-against-counterfeit-medicaldevices/ ) 2. Unifying Efforts against Counterfeiting Medical Devices, Saudi Food and Drugs Authority Initiative, Nazeeh Alothmany, PhD, Vice Executive President for Medical Devices and Equipment, Saudi Food and Drugs Authority, Third WHO Global Forum on Medical Devices Geneva, May 9th-12th, 2017 3. Barry McDonogh, Vice President of Business Development, TruTag Technologies Inc. h t t p s : / / w w w. m p o - m a g . c o m / c o n t e n t s / v i e w _ o n l i n e exclusives/2016-05-05/combatting-counterfeiting-in -medtech/

JIMIT MEDICO SURGICALS PVT. LTD.

Bhupesh Sood (MBA, IPR - WIPO (Switzerland), WHO AAR, Trainer and Auditor, Certified Six Sigma Green Belt, Data Science Foundation, MDR 2017, ISO 13485, ISO 9001, ISO 14001, ISO 45001, WCA)

Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries.

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Global Trends

COVID-19 and The Critical Role of MedTech COVID-19 is changing the face of healthcare at an unprecedented pace. MedTech has key role in tackling the virus . How to tackle some of the issues impacting MedTech, and its effect on the NHS (England).

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The MedTech industry is in the frontline here. It is playing a crucial role in ensuring that the right technologies are available, at scale and speed, for NHS providers and patients to combat the virus. Diagnostic tests are needed to rapidly identify those that are infected, as well as detect those that aren’t – in order to free-up resource and increase NHS capacity. Personal protective equipment (PPE) such as face masks, gowns, gloves, goggles and footwear are essential for preventing the spread of infection and protecting healthcare professionals. And life-saving care also needs to be available to all COVID-19 patients. Respiratory support equipment is the most obvious need, accompanied by a plethora of equipment necessary for the care of patients with severe symptoms such as infusion pumps, syringe pumps, pump consumables, IV access, ICU equipment, catheters, artificial feeding equipment and hospital beds. Unsurprisingly, COVID-19 is putting the supply chain for MedTech products under pressure. The impact of this will of course vary by company, based on product portfolio. Some will see the need to mobilise extra manufacturing resources to meet increased demand. Where that demand can’t be met, the government is looking to other manufacturers (and in other industries) for help. The ‘ventilator challenge’ for example, is seeking widespread production of respirators to ensure capacity and capability is met in the NHS critical care setting. Other MedTech companies may see demand for their products decline, for example, companies that manufacture equipment used solely in elective procedures, which are being postponed due to COVID-19. R&D programs are also affected as many hospitals and researchers are having to deprioritise product evaluations. Industry should aim to help its NHS customers and their patients through this challenging time, becoming a critical part of mitigating its impact on individuals.

MedTech companies will need to think carefully about how and what their sales personnel, medical liaison staff, and others communicate to their NHS customers. Messaging about the strength and capacity of their services, including continuity and speed of supply, product quality, patient outcomes and other reassurances are likely to resonate.

Engaging your NHS customers But with the current limitation on non-essential personnel in offices, and the understandable restrictions on hospital access, how can MedTech best engage to support their NHS customers? A relatively simple solution is to replace physical meetings with digital meetings, leveraging the latest technology in video conferencing to maximise engagement. Some companies are questioning whether it’s responsible to be requesting any time from NHS staff during this period. With this in mind, MedTech should also consider other channels for remote customer engagement, moving towards an ‘on-demand’ model of contact.

Helping teams to be ‘responseready’ MedTech could use this time to build customer access strategies and plans. It’s unlikely that the NHS will revert to business as usual (BAU) so considering the prevailing issues in a postcoronavirus world against your business challenges, provides an opportunity to discover new ways of creating value for your NHS customers. If the ‘new normal’ includes the limiting of face-

Global Trends to-face gatherings it is likely to result in cancelled or postponed training sessions, conferences and events. Engaging in online learning, not to simply occupy some ‘downtime’ but to build the capabilities you and your colleagues will need to thrive in a postcoronavirus world.

A new NHS landscape? MedTech companies may also discover that they are working within a new landscape of providers who have integrated at pace. The COVID-19 crisis will be a true test of how far social care, the community and third sector, and independent sector providers are really embedded, as they work together to relieve the burden on hospitals, and use primary, community and care settings to create critical care capacity.

For example, NHS England’s guidance said that when assessing if a patient was ready to go home, doctors were not to ask if the patient is “medically fit” or “back to baseline” but instead if they were “medically optimised”. It acknowledges this will require patients to receive ambulatory heart failure treatment, intravenous antibiotics and oxygen at home or in a community setting. Systems, not hospitals, will have to take on many of MedTech’s patient groups previously based in acute care. What’s clear is that MedTech will need to understand its morphing customer base to fully support the effort, and to be as adaptable and agile as the NHS is having to be. (Ref : https://wilmingtonhealthcare.com/covid-19and-the-critical-role-of-medtech/ )

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Labeling Requirements – Compliance to Law Medical Devices will be regulated w.e.f. 1st April, 2020 in a phased manner. While there is a transition period of one and a half year for complying with MDR 17, there is no exemption currently available for penalties under the Drugs Act and also for Compliance to DPCO 2013 (Drugs Price Control Order 2013). Industry needs to be additionally complying with the Labeling requirements of the Legal Metrology (Packages Commodities) Amendment Rules, 2017. Even as on date under these Rules all Manufacturers of Medical Devices are expected to adhere to the MRP and Labeling requirements – please refer to the Notification No. GSR 629 (E) dt 23rd June, 2017 of Ministry of Consumer Affairs and the Clarification received from Ministry of Consumer Affairs for the clarification sought.

Under the DPCO Rules a Manufacturer can’t raise his MRP by more than 10% a year so if you are not being labeling your MRP please ensure to do so now to avoid getting penalized by the Regulators. For the Guidelines for framing the MRP, AiMeD has prepared White Paper on Affordability enclosed. The Association is seeking from NPPA and exception to the Labels of MRP for Medical Equipment, other than for over the Counter, homecare Medical Electronics, as well as for IVD Reagents other than OTC Products. Labeling requirements and checklist for unit of sale is given below. For any clarification regarding MRP or related issues on Labeling, please contact “AiMeD”.

ANNEXURE – II CHAPTER VI (MDR 2017) LABELLING OF MEDICAL DEVICES 44. Labelling of medical devices :- The following particulars shall be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, namely,(a) name of the medical device; (b) the details necessary for the user to identify the device and its use; (c) the name of manufacturer and address of manufacturing premises where the device has been manufactured; (d) the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package expressed in metric system; (e) the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product): Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the device: Provided further that where the device is made up of stable materials such as stainless steel or titanium, and supplied nonsterile or in case of medical equipment or instruments or apparatus, the date of expiry may not be necessary. Explanation.- For the purposes of this clause, the date of expiry shall be in terms of the month and the year and it shall mean that the medical device is recommended till the last day of the month and the date of expiry shall be preceded by the words “Expiry date” or “Shelf Life”; (f) to provide, wherever required, an indication that the device contains medicinal or biological substance; (g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” Or “B. No.”; (h) to indicate, wherever required, any special storage or handling conditions applicable to the device; (I) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilization method;

(j) to give, if considered relevant, warnings or precautions to draw the attention of the user of medical device; (k) to label the device appropriately, if the device is intended for single use; (l) to overprint on the label of the device, the words “Physician’s Sample – Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample; (m) to provide, except for imported devices, the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M.L.”; (n) to provide on the label, in case of imported devices, by way of stickering, where such details are not already printed, the import licence number, name and address of the importer, address of the actual manufacturing premises and the date of manufacture: Provided that the label may bear symbols recognized by the bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of the text and the device safety is not compromised by a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user; (o) in case of small sized medical devices on which information cannot be printed legibly, shall include the information necessary for product identification and safety such as information covered by clauses (a), (b), (c), (d), (e), (g), (k), and (m) shall be included. ICEMED LABELLING CHECKLIST REQUIREMENTS FOR MEDICAL DEVICES A. Information mandatory to be marked on the ‘Unit pack for sale’ of device. 1. Name / Trade Name of the device. 2. The Name & Address of manufacturer 3. Lot / Batch No. 4. Date of Expiry 5. Indication for single use (if applicable) 6. The word STERILE” (For Sterile Devices)

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7. Caution in event of damage to sterile pack 8. Max. Retail Price B. If space constraint “unit pack for sale”, the following information is also mandatory on secondary pack of Device, user/ consumer can be cautioned by use of caution symbol on the unit pack. 1. Device description 2. Mfg. Lic. No. (if applicable) 3. Dateof Mfg. 4. Storage / handling instruction 5. Operating instruction / instruction for use, where appropriate 6. Method of sterilization (For Sterile Devices) 7. Warning / Precautions & Symbols (if applicable) 8. Customer – Care – Contact Detail. Note 1. As far as it is practicable and appropriate, the information needed to identify and use the device safely should be provided on the device itself, and/or on the packing for each unit, and /or on the packaging of multiples devices. Note 2. As far as practicable and appropriate, the information

needed to use the device safely to be given on the Device itself and/or on the packing for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information to be given in the leaflet / information to Use supplied with one or more Devices. Note 3. Each Device to be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. Note 4. Where appropriate, the information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized Standards. In areas for which no Standards exist, the symbols and colours must be described in the documentation supplied with the Device”. Graphical symbol as per ISO 15223 can be used as appropriate for all of above. Any additional labeling requirement specified in related product standard to be included appropriately. Note 5. The unit pack can be containing more than one number or type of medical devices.

AiMeD Welcomes Govt’s Schemes For Promotion Of The Domestic Manufacturing Of Medical Devices New Delhi: The Union Cabinet chaired by the Prime Minister, Shri Narendra Modi has approved the following schemes today for promotion of the Domestic Manufacturing of Medical Devices in country: 1. The scheme on Promotion of Medical Device Parks for financing Common Infrastructure Facilities in 04 Medical Device Parks with financial implications of Rs. 400 crore. 2. The Production Linked Incentive (PLI) Scheme for promoting domestic manufacturing of medical devices with financial implications of Rs. 3,420 crore. Applauding the Govt. and thanking the Prime Minister during a video conference Mr. Rajiv Nath, Forum Coordinator, AIMED on behalf of the Indian Medical Device Industry said “We congratulate the Government wholeheartedly for approving the much needed schemes for promotion of the Domestic Manufacturing of Medical Devices in country and thanked the Prime Minister for recognition of the need to have self sufficiency in India in Medical Devices. Nath appraised the Prime Minister of the steps being taken by DoP & NPPA & DoCA in addressing the accessibility to raw material issues which were holding back manufacturers from fully utilising their production capacities as well as the need for local administration at various states to recognise the need for medical devices to be treated as an essential product and no steps to be taken to hamper movement of men and materials to produce or sell them but instead to facilitate the import of raw materials and components by cargo airfreight if passenger flights were restricted as well as by continuing courier services. “We are more than hopeful that these schemes announced would help boost local manufacturing and will accelerate medical

devices manufacturing as a 'Make in India' enabler, make quality healthcare accessible and affordable for common masses, enable placing India among the top five medical devices manufacturing hubs worldwide and help end the 80-90 per cent import dependence forced upon us and an ever increasing import bill of over Rs 38,837 crore,” he opined. Such a visionary move by the Govt. will help address Indian National Healthcare security concerns – the inadequacy of which is being exposed in ongoing crisis to address the Coronavirus pandemic preparedness but the domestic industry was rising to the challenge to meet the health care needs of the country – whether, masks, gloves, sanitizers, injection syringes or ventilators and oxygen lines. Nath stated, “We further await policy announcement on the below vital issues of Indian Medical Devices Industry: • Govt. must ensure consumers are not hurt by shortages by monitoring of prices at import or at ex factory level and of the MRP and proactive steps taken to regulate prices but not overly so that it leads to further shortages and become non remunerative for manufacturers and traders. · Need to Regulate all Medical Devices under a Patients' Safety Medical Devices Law separate from Drugs to protect patients and aid responsible manufacturing. • Restriction on Import of Pre-owned Medical Equipment · While we thank the Govt of deploying 5% Cess on some imported devices to encourage employment and Make in India of Medical Devices , to address 70-90% import dependency we seek a predictive nominal tariff protection policy as done for mobile phones to ensure a vibrant domestic industry & competitiveness and price stability driven by competing Mar.-Apr. 2020

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domestic players • Need to incentivize Quality in Healthcare Products in public healthcare procurements by preferential pricing for Q1 e.g. ICMED (QCI's Indian Certification for Medical Devices) instead of L1 (lowest price) to ensure patients access acceptable quality. The Prime Minister was highly concerned about the highly contagious coronavirus infection which had extended its imprint to 283 cases in India on Saturday and had sought cooperation from Pharma Associations – IPA , IDMA, BDMA etc , AIOCD and Medical Devices Association AiMeD during the all India VDO Conference. With the rapidly growing number of positive infected coronavirus cases in India, one of the major challenge the country is needlessly facing are avoidable shortage of safety masks made worse by anxious civilians hoarding medical supplies though these are not prescribed for healthy individuals and need to educate them. “Public is panicking and hoarding up masks and other equipment, leaving limited supplies for health care professionals who need the gear the most. We are creating an avoidable supply chain diversion from supplies to Healthcare workers who are at greater coronavirus risk. Who will protect those who protect us ?” Rajiv Nath said. “We are ramping up capacity utilization with assistance of Govt.

to address raw material bottlenecks of alcohol, non woven material and assure availability but appeal to consumers not to buy needlessly and hoard products,”added Mr. Nath. Another critical issue is with demand rising more than 10 times by this individual consumers rush , the country is not only witnessing surge in prices of medical masks and hand sanitiser but the domestic market is now flooded with sub-standard and lowquality products as some retailers and unorganised mask manufacturers are cashing in on the virus terror. Mr. Shinde President of AiOCD affirmed to the Prime Minister that together with AiMeD Association of Indian Medical Devices Industry we have pledged to not charge beyond MRP and assure the government to work against profiteering and black marketing and hoarding. “The government has thankfully quickly taken some much needed drastic and bold steps to curb the unethical behavior in the market, but lot needs to done by all of us – Manufacturers, Traders & Consumers to address the challenge of avoiding shortage of masks for the healthcare professionals and of Sanitizer to the Consumers and ensure availability at reasonable prices and quality products to jointly fight Coronavirus.” Concluded Mr. Nath. https://indiamedtoday.com/aimed-welcomes-govts-schemesfor-promotion-of-the-domestic-manufacturing-of-medicaldevices/

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Industry News NPPA Notifies All Medical Devices As Drugs Under DPCO-2013 For Quality Control & Price Monitoring National Pharmaceutical Pricing Authority (NPPA) has notified all medical devices as drugs under provisions of the Drugs Prices Control Order (DPCO-2013) with effect from April 1, 2020 . “Thus, all medical devices shall be regulated by the government as drugs for quality control and price monitoring. The maximum retail prices (MPRs) of all the medical devices would be monitored by the government under the provisions of Para 20(1) of the DPCO, 2013 to ensure that no manufacturer/importer increases the MRP of a drug more than ten percent of MRP during preceding twelve month and where the increase is beyond ten percent of maximum retail price, it shall reduce the same to the level of ten per cent of maximum retail price for next twelve months,” Further, as per Para 20(2) of the DPCO, 2013 read with the Essential Commodities Act, 1955, the manufacturer/importer shall also be liable to deposit the overcharged amount along with interest

thereon from date of increase in price in addition to penalty. Government is regulating 24 class of medical devices which have been notified/regulated as drugs under Drugs & Cosmetics (D&C) Act, 1940 and D&C Rules, 1945. Of the above, 4 medical devices viz. (i) Cardiac Stents (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Device (Cu-T) are scheduled medical devices for which ceiling prices have been fixed. These 4 medical devices are under price control. As regards remaining non-scheduled medical devices which are notified/regulated as drugs, NPPA is currently allowing MRPs under Para 20 of the DPCO, 2013 to ensure that no manufacturer/importers can increase the price more than ten percent in preceding twelve months. (Ref:http://www.pharmabiz.com/NewsDetails.aspx?aid=122187& sid=1, April 3, 2020 )

Govt Announces Rs. 13,760-cr Package To Boost API & Medical Device Production In India, Industry Cheers Up With the coronavirus outbreak disrupting supply of active pharmaceutical ingredients (APIs) and medical devices from China to India, the government has come out with four schemes worth Rs 13,760 crore to encourage manufacturing of bulk drugs and medical devices in the country and their exports. On March 21, the Union Cabinet under the chairmanship of Prime Minister Narendra Modi had approved an expenditure of Rs. 9,940 crore and Rs. 3,820 crore for APIs and medical devices, respectively. The PLI scheme for promoting domestic manufacturing of medical devices will have financial implications of Rs. 3,420 crore for next five years. The medical device sector suffers from a cost of manufacturing disability of around 12 per cent to 15 per cent, vis-a-vis competing economies, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on R&D and skill development, etc. There is, thus, a need for a mechanism to compensate for the

manufacturing disability. The PLI scheme aims to boost domestic manufacturing by attracting large investments in medical device sector. Under the scheme, incentive at the rate 5 per cent of incremental sales over base year 2019-20 will be provided on the segments of medical devices identified under the scheme. Under the sub-scheme for promotion of medical device parks, common infrastructure facilities would be created in four medical device parks, which is expected to reduce manufacturing cost of medical devices in the country. Welcoming the government’s initiative to promote medical device manufacturing in India, RajivNath, forum coordinator, AiMeD said “Such a visionary move by the government will help address Indian healthcare security concerns- the inadequacy of which is being exposed in ongoing crisis to address the coronavirus pandemic preparedness. The schemes announced will help boost local manufacturing.” (http://www.pharmabiz.com/NewsDetails.aspx?aid=121939&sid= 1 , March 24, 2020 )

Cabinet Approves Promoting Domestic Manufacturing Of Medical Devices The Union Cabinet chaired by the Prime Minister, Narendra Modi has approved following schemes: 1. The scheme on Promotion of Medical Device Parks for financing Common Infrastructure Facilities in 4 Medical Device Parks with financial implications of Rs. 400 crore. 2. The Production Linked Incentive (PLI) Scheme for promoting domestic manufacturing of medical devices with financial implications of Rs. 3,420 crore. • Production Linked Incentive Scheme 1. The Medical Device sector suffers from a cost of manufacturing disability of around 12% to 15%, vis-a-vis competing economies, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on R&D and skill development, etc. There is, thus, a need for a mechanism to compensate for the manufacturing disability. 2. The Scheme aim to boost domestic manufacturing by attracting large investments in medical device sector. Under the Scheme, incentive @ 5% of incremental sales over base year 2019-20 will be provided on the segments of medical devices identified under the Scheme.

Implementation: The Scheme for Promotion of Medical Device Parks will be implemented by a State Implementing Agency(SIA). The PLI Scheme for promoting domestic manufacturing will be implemented by a Project Management Agency (PMA) to be nominated by Department of Pharmaceuticals. The target is to provide financial assistance for Common Infrastructure Facilities for 04 Medical Device parks. The target for PLI Scheme is to provide assistance to about 25-30 manufacturers under the following categories of medical devices: 1. Cancer care/Radiotherapy medical devices, 2. Radiology & Imaging medical devices (both ionizing & nonionizing radiation products) and Nuclear Imaging Devices, 3. Anesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices and 4. AII Implants including implantable electronic devices like Cochlear Implants and Pacemakers. (https://www.biospectrumindia.com/news/22/16011/cabinetapproves-promoting-domestic-manufacturing-of-medicaldevices.html , 24 March 2020 )

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Product Gallery Single-Use Bioprocessing Components

R o n k o n k o m a , N Y, U S A , A p r i l 7 , 2020—Qosina carries a broad selection of instock, single-use bioprocessing components. The company provides 3D CAD models and comprehensive technical specifications, such as material safety data sheets, technical data sheets, material certification and compatibility information on most of these products. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, reflecting its unwavering commitment to providing high quality products backed by business continuity, consistent quality and change control that meet customer expectations and comply with industry standards. Single-use components in Qosina’s bioprocessing line include tubing, sanitary couplings, bag ports, aseptic connectors and more. Browse popular brands like CPC AseptiQuik®, Pharmafluor®, PharmaLok™, BioValve™, BioClamp™ and BioEnd Cap™. Visit https://www.qosina.com/bioprocessing-2 to see the full line. For more information about single-use systems and how they can be beneficial in a global crisis like COVID-19, read Qosina’s latest

blog post: https://www.qosina.com/singleuse-systems-for-bioprocessing. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries.

Components To Reduce Critical Enteral Misconnections

R o n k o n k o m a , N Y, U S A , M a r c h 4 , 2020—Qosina is the trusted supplier of enteral components for medical devices, offering over 250 off-the-shelf products including a wide selection of legacy feeding tube connectors and fittings. Also included in Qosina’s enteral application product line is its robust collection of ENFit™ connectors, caps and plugs, stopcocks, spikes, and syringes. ENFit™ components comply with the ISO 80369-3 standard, which was developed to improve patient safety and reduce the risk of small-bore misconnections used in liquid healthcare applications. The ENFit™ connector was designed using a non-traditional orientation and larger dimensions that do not allow connectivity with the common conical luer (formerly ISO 594, now ISO 803697). The ENFit™ connector has been tested using a strict validation process that includes human factors research, usability analysis, performance testing, misconnections assessment and computer-aided design techniques. To learn more about Qosina’s enteral and ENFit™ products, visit https://www.qosina.com/enteral. Qosina adheres to the strictest of quality standards and is committed to providing high quality products.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries.

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Press Release

Qosina Provides Business Update Regarding COVID-19

Ronkonkoma, NY, USA, March 17, 2020—Qosina Corp President and CEO Scott Herskovitz today released a statement to customers regarding COVID-19 and the actions the company is taking to handle this unprecedented situation: “As always, we are committed to serving our customers, while at the same time ensuring the health and wellness of our employees. With the incredible speed at which things are changing around us, we are continually adapting our operations and business. Several weeks ago, we established a COVID-19 task force. We have since put the following precautionary measures into action:

Business continuity management Qosina’s ISO 22301 business continuity management system has been activated. Our crisis management team developed an emergency plan to ensure that our mission critical functions are up and running so that we may continue to provide you with an outstanding level of service. Our customer service, sales and supplier teams remain active, even in the event of a forced closure. The crisis management team meets regularly to monitor the situation, and modify and communicate the plan as the need arises. Once the COVID-19 crisis has passed, the team will work on transitioning Qosina back to normal operations.

Supply chain management We are actively monitoring our global supplier network and freight lanes to identify any risks of business interruption. We conduct daily internal meetings to review and discuss the ever-evolving situation surrounding COVID-19 and are working closely with our larger customers to identify unforeseen changes in demand. If you anticipate any significantly higher or lower purchases in the foreseeable future, please let us know so that we may focus our efforts to serve you at the highest level. Additionally, our vendor relations team communicates with our suppliers several times a week. Currently, all of our suppliers are operating on normal schedules. Qosina is also operating on regular delivery schedules, but depending on the location and any directives from local authorities and the United States government, the situation could change very rapidly.

Business travel and in-person meetings We have halted business travel for our employees and restricted onsite visits to our facility. We have phone and videoconferencing tools at the ready to conduct virtual meetings. We feel this is an effective way to conduct business while simultaneously minimizing health risks.

Employees working remotely We have begun implementing occupancy and social distancing guidelines as recommended by the CDC, and tested our secure remote access systems and technology infrastructure to adjust working arrangements for our employees. We have encouraged our staff to work from home to the greatest extent possible, while also ensuring their availability. We have a very solid internal communications system and can remain operational with a remote staff.

Extreme cleaning measures Qosina has implemented additional steps to ensure we maintain a higher level of cleanliness in our facility. Our cleaning service is regularly performing a deep cleaning and disinfecting of all common areas. In addition, we’ve supplied all employees with cleaning kits to frequently disinfect their workstations. Our chief concern is everyone’s health and wellness, and our thoughts are with our customers, employees and communities. As we continue to monitor the situation, additional changes in our operations may be necessary in order to comply with government guidelines. We will keep you posted as we navigate through this challenging and uncertain time. Please also visit our website for news and updates, as we will share them when they become available. If you have any questions or concerns, please reach out to any member of our customer support team. As always, thank you for your continued partnership and support. Best wishes to you, your families and colleagues.” Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries.

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• Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

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I.V. Infusion Sets Blood Administration Sets Scalp Vein Set Urine Collection Bags Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.

• ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter

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Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

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