The Central Drug Standard Control Organisation under the provisions of the Medical Device Rules 2017, authorized to conduct audits of manufacturing sites in accordance with the stipulations outlined in the rules.

The Central Drug Standard Control Organisation (CDSCO) in India comprises the Central Licensing Authority (CLA) and State Licensing Authority (SLA), responsible for licensing processes related to import, manufacturing, distribution, sale, stocking, exhibition, or offering for sale.

The SLA designates a Notified Body to verify Quality Management System and Technical Review compliance for Class A & Class B Medical Device Manufacturers.

The CLA may enlist the services of a Notified Body to inspect the manufacturing sites of Class C and Class D medical devices, along with conducting Technical Reviews.

The Indian medical device market is poised for substantial growth in the coming years, driven by increasing health consciousness, a burgeoning middle class, and government health initiatives. In 2017, the Indian authorities revamped the regulatory framework for medical devices through the introduction of the Medical Device Rules.

Manufacturers seeking to register their medical devices in India are required to furnish evidence of approval in their home market. Additionally, presenting documentation of prior regulatory authorization in prominent regions such as the U.S., Canada, Europe, Australia, Japan, or the U.K. can streamline certain regulatory processes.

Submission of technical documentation for review by the Central Drugs Standard Control Organisation (CDSCO) is mandatory. Furthermore, all manufacturing facilities for the devices must be registered.

India presents an attractive market opportunity for global medical device manufacturers, as a significant portion of medical devices consumed in the country are imported. The Ministry of Health and Family Welfare's Notification No. G.S.R, 78(E) dated January 31, 2017, officially brought the Medical Devices Rules 2017 into effect from January 1, 2018.