On October 12, 2023, the CDSCO released a circular, extending the deadline by six months for manufacturers and importers dealing with non-notified Class C and Class D medical devices. Originally slated for mandatory licensing from October 1, 2023, this extension aims to smoothen the transition. In this article, we delve into the intricacies of the CDSCO circular and guide you through the approval procedures for Class C and Class D medical devices.

The circular grants manufacturers and importers of class C and D devices a six-month grace period to continue operations seamlessly. The shift to a fully licensed regime has triggered concern in the medical industry, prompting fears of a potential shortage of medical devices. Various stakeholders voiced apprehensions about the disruption. Acknowledging these concerns, the CDSCO extended the mandatory licensing timeline, allowing those who applied for licenses on or before September 30, 2023, to import or manufacture devices for an additional six months from 01^st Oct 23.

The registration process for medical devices in India is intricate and demands substantial documentation. The CDSCO serves as the central authority, responsible for issuing import and manufacturing licenses for all medical devices. Here's a concise breakdown:

– Register on the Sugam portal.
– Pay the prescribed fee.
– Submit an online application on Form-14 with required documents.
– Upon review and satisfaction, CDSCO issues an import license in Form-15.

– Register on the Sugam portal.
– Pay the prescribed fee.
– Submit an online application in Form MD-7 (or MD-8 for loan License) with the necessary documentation.
– Undergo an audit of manufacturing facility by Central Licensing Authority.
– Upon compliance and satisfactory inspection, receive the manufacturing authorization in Form 9 (or MD-10 for loan License).

The CDSCO’s extension of the licensing period addresses the medical device industry’s concerns, aiming to prevent disruptions in the manufacturing and import of medical devices. This initiative ensures a smoother transition to the new approval regime.

If you have still not submitted your application for Class C & D devices, we could assist you with the same. With over a decade of experience in the medical device regulatory domain, RSI has successfully registered 450+ medical devices across all categories and fostered success stories for clients from over 15 countries.

Explore RSI’s spectrum of services:

1. CDSCO Medical Device Registration
2. CDSCO Medical Device Import License
3. Wholesale License/Distributor License for medical devices
4. Post Approval Changes in Medical Device
5. Medical Device Label Compliance Review

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