India: CDSCO Reminds of the Medical Devices Class C & D of License Registration (30 September 2023)

All non-classified medical devices listed under Class C and Class D are authorized to undergo the licensing regime with full effect starting on 1 October 2023. The Central Drugs Standard Control Organisation (CDSCO) issued a Circular on 12 April 2023 so all the concerned manufacturers have approximately 6 months to prepare for the system transition.

At the moment, medical devices under Class C and D are under mandatory registration for 24 months after the voluntary registration phase. The mandatory registration phase starts from 1 October 2021 until 30 September 2023. The Circular acts as a reminder for all concerned manufacturers to prevent any product shortage in the market.

For a smoother manufacturing license application process based on Medical Devices Rules 2017 (MDR), CDSCO will carry out an inspection 60 days from the application date and ensure the manufacturer is MDR-compliance. Besides, the manufacturers are also advised to prepare all the document requirements and fees based on the MDR 2017.

• Details of the domestic manufacturer / authorized agent

• Plant master file (Appendix I of the Schedule)

• Device master file (Appendix II for non-IVD medical devices, Appendix III for IVD medical devices of the Schedule)

• Essential Principles checklist for Safety and Performance of the Medical Devices including IVD medical devices

• For domestic manufacturers – test license for testing and generation of quality control data

• Approval statement as evidence that the manufacturing site complies with the Fifth Schedule

All the applications will be processed efficiently in a short time, provided that all the requirements are complete so that the license can be issued at the right time preventing any product disruption in the market.

Source: Central Drugs Standard Control Organisation

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