India: New Medical Device Regulations

India’s Ministry of Health and Family Welfare has released long-awaited new medical device and in vitro diagnostic (IVD) regulations that separates regulatory norms for manufacturing medical devices from drugs.
The new rules are aimed to standardise and regulate the medical devices manufacturing industry on par with international standards. Currently there is no clear regulation on medical devices – some of them are regulated as drugs, for some other types of devices there is no formal regulation at all.

The new rules are based on the principles of the Global Harmonization Task Force (GHTF) (currently International Medical Device Regulators Forum (IMDRF) ) under which all medtech products are categorized in four groups based on their risk level, with Class A representing the lowest risk.

When the rules come into effect, the quality management system (QMS) of all device manufacturing sites will have to be aligned with the ISO 13485. The rules include strict timelines for most tasks undertaken by regulators and this is expected to bring certainty to the overall process, the health ministry said in a statement.

The new rules establish a system of appointing Notified Bodies to verify and assess the QMS of medical device manufacturers. Those Notified Bodies will be accredited by the National Accreditation Board for Certification Bodies (NABCB).

The Medical Device Rules will take effect in January 2018.

Press release: Health Ministry Notifies Medical Devices Rules, 2017.