Medical Devices Registration in Bangladesh

Overview

1.Bangladesh Medical Device Regulations

2.Medical Device Status

3.Medical Device Classification System

4.Medical Device Registration Process

Bangladesh Medical Device Regulations

In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards. DGDA’s role is pivotal in ensuring the efficacy and reliability of medical devices through stringent oversight and country registrations.

In Bangladesh, the Bangladesh Drug and Cosmetics Act of 2023, enacted on September 18, serves as the cornerstone of regulatory provisions governing medical devices and pharmaceuticals. This legislation addresses crucial aspects such as manufacturing, importing, distributing, and selling medical devices, primarily focusing on ensuring adherence to quality and safety standards.

One significant requirement outlined in the Bangladesh Drug and Cosmetics Act is the necessity for medical device registration. Manufacturers and importers must obtain country registrations from the appropriate regulatory authorities.

Medical Device Status

As of September 18, 2023, the Government of Bangladesh introduced the Drug and Cosmetics Act, 2023, outlining regulations for medical devices, IVD reagents, and software. This act expands the definition of medical devices, now encompassing software under drug regulations

According to the Drugs and Cosmetics Act, 2023, a medical device is defined as follows: “Medical device” encompasses:

(a) Various devices such as instruments, apparatus, implements, machines, appliances, implants, diagnostic reagents (in vitro, in vivo, and silico reagents), software, or related materials. These are used either independently or in combination for specific purposes, including:

(i)Diagnosis, prevention, monitoring, treatment, or alleviation of diseases or disorders;

(ii)Diagnosis, monitoring, treatment, alleviation, or assistance for injuries or disabilities;

(iii) Investigation, replacement, anatomy or physiological processes;

(iv)Supporting or sustaining life;

modification, or support of

(v)Conception control or medical device disinfection;

(vi)Providing information through examining and analyzing samples collected from human or animal bodies, unaffected by pharmacological, immunological, or metabolic actions.

(b) Additionally, any device or diagnostic reagent declared by the government, through notification in the Official Gazette, for this Act. This comprehensive definition broadens the scope of medical devices under the regulatory purview, ensuring the safety and efficacy of products intended for use in Bangladesh. It underscores the importance of adherence to regulations for manufacturers seeking medical devices registration in Bangladesh.

Medical Device Classification System

Medical Device Registration Process

Submission of Applications

Document Preparation

Review and Approval

Registration Certificate Issuance

Renewal

Compliance Assessment

Post-Market Surveillance

Inspection

At Maven, our commitment goes beyond offering exceptional services; we prioritize keeping our clients informed about Bangladesh’s evolving regulatory landscape, especially concerning medical devices registration. Our proactive approach ensures clients stay updated on any pertinent updates, be they changes in compliance standards or approaching registration deadlines.

We recognize that compliance is just one aspect; our ultimate goal is to empower businesses to reach their full potential globally.

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