Introduction:

On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India released a circular reminding Indian manufacturers and importers that all Class C and Class D non-notified medical devices, currently under mandatory registration, will require a full license starting October 1, 2023. This blog will provide you with an overview of the new licensing regime and assist you in transitioning to the new license requirements.

It is important first to understand what is meant by a non-notified medical device. These are medical devices which have fallen under the ambit of the licensing regime after the adoption of the new enlarged definition for Medical Devices by Ministry of Health & Family Welfare in Feb 2020. (Not sure whether your device is non-notified or not? We can help)

This full license requirement deadline is the final step for transiting the Class C & Class D non-notified medical devices to the Licensing regime.  Currently, all class C and D non-notified medical devices are exempt from Manufacturing/Import licence and can be manufactured/ imported into India basis their mandatory registration with CDSCO. From October 1, 2023, for such devices, it will compulsory to have a license if you want to introduce your medical device in India.

For medical device importers:

Getting a CDSCO medical device import license in India can take up to six months post the submission of application. The preparation for the application submission is also a time-consuming process and can easily take 1-3 months depending on the level of preparedness of an organization. Hence, it is important that all Class C and Class D non-medical device importers apply for the import license at the earliest to avoid any business disruption post 1st Oct 23.

For medical device manufacturers:

Similarly, obtaining a medical device manufacturing license in India is a time consuming process involving not only the extensive documentation but also an inspection by a Medical Device Officers of the Central Licensing Authority (CLA) within 60 days of application submission. Hence, if you have not started the application process, there is an urgency to do so now to maintain business continuity.

Conclusion:

The transition from mandatory registration to manufacturing/import license for Class C and D non-notified medical devices is the final step towards the full licensing regime for such devices. Manufacturers/importers need to be aware of the new regulation and take proactive steps to obtain a manufacturing/ import license. Given that CDSCO can take up to 6 months to issue a license there is an urgent need for impacted importers/manufacturers to start their application process immediately, if not done till now. Timely compliance will not only avoid disruption in the supply chain but also ensure continued access to these medical devices for patients.

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