A comparative study of medical device regulations in India: Before and after the implementation of medical device rules 2017

The medical device industry in India is one of the fastest growing commerce in the world as it is growing at a rate of 15.8% CAGR (Compound Annual Growth Rate) vis-a-vis a CAGR of 4.1% for the global medical device industry. Since 1940, medical devices were regulated as per Drug and Cosmetic Act 1940 and Rules 1945, CDSCO (Central Drug Standards Control Organization) regulated only a handful of medical devices through gazette notifications, these devices being called as notified devices. The application for import license for Class A or Class B medical devices from Unregulated Jurisdictions can be granted on the basis of a free sale certificate and either of published safety and performance data or clinical investigation in the country of origin. [...]in case of license to manufacture Class C or Class D medical device, the scrutiny of the application is required to submitted within forty five (45) days of the date of the application, the inspection of the manufacturing site is required to be completed before sixty (60) days from the date of the application, the report of the inspection has to be forwarded to the applicant, and the decision on the application has to be communicated within forty five (45) days from date of receipt of the inspection report. (5) Similarly, a decision on application to import a medical device is required to be communicated within 9 months from the date of the application irrespective of whether the foreign manufacturing site is inspected or not. () The 2017 Rules have also introduced the concept of deemed approval in event of non-communication of a decision in application for approval to undertake major change in licensed particulars (the subject of major change in licensed particulars is discussed later in detail).