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India: 2018 Medical Device Regulations

June, 2018

Medical ministry of health and Family welfare released new medical device rules in February 2017 and the new rules got implemented from 2018. Outside of the list of just 10 devices, medial devices were not regulated in India and medical device companies wanted to penetrate India’s market just needed an import license. However, this policy is no longer sufficient for India’s medical device industry with the implementation of the new rule. The notification lists the medical devices and IVD devices with their risk classes: List A includes a total of 351 medical devices in 16 categories with their risk class as per the provisions of sub rule (1) of Rule 4 of MDR, 2017 which prescribes that medical devices shall be classified on the basis of parameters specified in Part 1 of the First schedule in the following classes namely Low risk – Class A; Low moderate risk – Class B; Moderate high risk – Class C; and High risk – Class D. List B includes a total of 247 in vitro diagnostic medical devices in 22 categories with their risk class as per provisions of the Sub-rule (2) of Rule 4 of the MDR, 2017 which prescribes that "IVD medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely, Low risk – Class A; Low moderate risk – Class B; Moderate high risk – Class C; and High risk – Class D.

To apply for import license, the authorized agent having a license to manufacture for sale or distribution or wholesale license for sale or distribution shall make an application for grant of import license for medical device to the central licensing authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD14 FOR OBTAINING a license. Once the application is received, the inspection of overseas manufacturing site is done, if the manufacturing site is present outside the country. On receipt of an application, the Central Licensing authority may cause an inspection of the overseas manufacturing site either by itself or by another other body to whom the power has been delegated for the purpose. Central Licensing Authority, on being satisfied, grant license in form MD-15 or, may reject such application for which reasons shall be recorded in writings, within a period of nine months from the date of application. In the event of rejection, the applicant may appeal to the Central government within a period of 45 days. Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a license shall be granted under a sub-rule (1) to the applicant without carrying out clinical investigation. Whereas, a medical device is imported from countries other than those referred to in sub-rule (3), the license in case of class C and class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation of India.

Whereas permission to import or manufacture new invitro diagnostic medical device, an application for grant of permission to impact or manufacture a new invitro diagnostic medical device may be made to the Central Licensing Authority in Form MD-28 either by authorized agent in case of import or a manufacturer himself, as the case maybe, and shall be accompanied with fee as specified in the second schedule along with information specified in part of Fourth Schedule, provided that the new invitro diagnostic medical device used for diagnosis of life threatening, serious diseases or diseases of special relevance to the Indian Healthcare Scenario, national emergencies, extreme urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no diagnostic medical device available in the country, the clinical data requirements may be abbreviated, deferred or omitted as deemed appropriate by the Central Licensing Authority.

- Arpitha
Healthcare Market Research Analyst
Infoholic Research