All medical devices in India to be regulated as “drugs”

The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. The immediate consequence of the amendment in law is as follows: Before October 1, 2021, all presently unregulated medical devices will have to be registered by respective importers or manufacturers with the Drugs Controller General of India. However, those medical devices which are already regulated or have been notified to to be regulated are exempted from the requirement of registration (see list of 37 categories of medical devices at the end of this article which are exempt from registration). Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (low-medium risk) medical devices sold in India will have to compulsorily obtain a license. Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of presently unregulated Class C (medium-high risk) and Class D (high risk) medical devices sold in India will have to compulsorily obtain a license. In order to obtain registration for medical devices, the importers and manufacturers of the medical devices have to be certified as compliant with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes).