Import of Diagnostic Devices: Everything you need to know! What are diagnostic Devices? The medical equipment’s which are useful in identifying the cause or nature of a certain phenomenon, commonly in relation to a medical condition are known as diagnostic devices. Commonly used diagnostic tools include stethoscope, sphygmomanometer, ophthalmoscope, otoscope, electrocardiograph and thermometer etc. Scope of Diagnostic devices Medical diagnostics involves the conduct of test for various purposes namely: 1. 2. 3. 4.
Risk assessment Early diagnosis Treatment Disease management
Diagnosis of diabetes, in the 17 century was done by measuring the level of sweetness in urine sample. Currently in vivo, or within the body, diagnostic tests encompasses computed tomography scan, magnetic resonance imaging, and blood pressure screening. Whereas in vitro, or from an external body specimen, diagnostic tests include cholesterol, Papanicolaou (Pap) smear, and glucose monitoring tests. For what purpose diagnostic devices are used? Diagnostic Devices and supplies help the clinicians to make an observation with respect to the patient’s health in order to prescribe suitable treatment. Such medical equipment’s accord a place in emergency rooms, outpatient care centers and intensive care units. Commonly used diagnostic tools include stethoscope, sphygmomanometer, ophthalmoscope, otoscope, electrocardiograph and thermometer etc. Steps to obtaining license for import of diagnostic devices in India Chapter 5 of the medical rules 2020, deals with the regulations with regard to the import of diagnostic devices for sale and distribution in India.
1. Application for grant of import license: Sub rule (1) of Rule 34 of the above said rules puts forth that in order to obtain license, an application is required to be made to the Central Licensing Authority through SUGAM an online portal of the Ministry of Health and Family Welfare in Form MD-14 by an authorized agent having license to manufacture for sale or distribution or by any wholesale licence who wishes to import medical devices for sale and distribution. The application has to be submitted along with the fee specified in the second schedule of the said rules. 2. Submission of application: The application must be submitted through SUGAM which is an online portal as mandated by CDSCO. 3. Documents to be submitted: The application must be submitted along with the following documents, namely: a) Power of attorney must be accompanied with the application for issuance of import license b) Name & address of foreign manufacturer c) Name & address of manufacturing site d) Submission of Free Sale certificate along with application e) Quality certificate of foreign manufacturers f) Details about manufacturing procedure of medical device g) Technical and clinical data of the medical device being imported 4. Grant of license: Central Licensing Authority on being satisfied will issue the license in form MD-15. [sub rule 1 of Rule 36] 5. Validity of license: Unless cancelled or surrendered, the license granted remains valid in perpetuity. Import License Fees:
Class A: 1000 USD (for one site), 50 USD for each distinct medical device
Class B: 2000 USD (for one site), 1000 USD for each distinct medical device
Class C or Class D: 3000 USD (for one site), 1500 USD for each distinct medical device
Conclusion: In the nut shell it can be said that the medical devices industry is ever growing and proving useful for curing different medical conditions. The industry ranges from small stents to MRI’s. The medical Devices rules governing the diagnostic devices is a curtain raiser and open portals for new opportunities in the industry. The medical devices rules are framed aligned with best international practices.