The Medical Devices Rules, 2017-Industry Implications And Action Required

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The medical devices sector has largely en-joyed a free hand from the regulators in India, as the sphere has largely gone unregulated thus far. Presently, there is no medical devices specific legislation specifying inter alia standards of safety and quality for most of the medical devices. Only a handful of devices such as cardiac stents, disposable hypodermic needles/ syringes, catheters, etc. make the cut of being classified as a 'drug and thus being regulated under the Drugs and Cosmetics Act, 1940 (Act). Other medical devices presently have no legal provisions governing the aspects of manufacture, product standards, sale or distribution.

This unwarranted but longstanding position is extremely short-lived, with the Medical Devices Rules, 2017 (MDR 2017) coming into effect on January 1, 2018. While the wheels of this regulatory framework were set in motion with its notification on January 31, 2017, the Government thought it is best to give the stakeholders ample time to prepare for the paradigm shift in the regime. That being said, the first National Accreditation Board (Board) has already been recognised under the MDR 2017 with effect from January 31, 2017 itself. The Board is going to start entertaining applications for registration as Notified Bodies from July 1, 2017, which, amongst other things, would be empowered to carry out audit of manufacturing sites of low as well as low moderate risk category medical devices from the next year.

Taking the right first steps are often the most important bit of the journey. In view of the impending MDR Rules, below are some key steps that need to be undertaken by the entities engaged in import, manufacture, sale or distribution and clinical investigation of the medical devices:

Determining whether the products fall within the MDR 2017 categorisation