New licensing guidelines And Timelines For Non-Medical Devices

 CDSCO issued guidelines for medical device registration India with a voluntary registration timeline coming to an end. Those medical devices that fall under Class A and Class B fall under licensing rule rom  October 1, 2022, while those medical devices falling under Class C and Class D will be covered under the Licensing Regime a year after that as per Central Drugs Standard Control Organization.

The CDSCO released guidance document to assist the industry that has come out with various queries. Many are just basic FAQs, even if compulsory registration for class A and Class B will start in a few days.

In a guidance document given to manufacturers as well as importers for voluntary as well as compulsory registration, it was said by the organization that registration of class A, B, C, D devices is kept voluntary for about 18 months, right from April 1, 2020, to September 30 2021.

Voluntary registration of Class A and B devices is followed by mandatory registration for about 12 months after 18 months of the voluntary registration period is complete, that is, till September 30, 2022.

From October 1, 2022, medical devices under class A and class B fall under the licensing regime as per the guidance document. Voluntary registration of medical devices under class C and Class Dis followed by mandatory registration for about 24 months after 18 months voluntary registration period is completed from October 1. 2021 to September 30 2023. Starting from October 1, 2023, class C and class D devices will come under the licensing regime.

Documents needed for registration of medical devices by Manufacturers

●        Name and address of the firm or company, or entity that manufactures the medical device.

●        Name and address of the manufacturing site of medical devices

●        Detail of medical device

●        Proof of compliance with ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device

●        An undertaking by the manufacturer that states that the data furnished by the applicant is true as well as authentic.

Documents required for medical device registration by importers

●        Name of the company or entity that imports the medical device

●        Detail of the medical device

●        Specification and standard of that medical device

●        Proof of compliance with ISO 13485

●        Free sale certification by country of origin.

●        An undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic

The guidance document also offers all steps that manufacturers and importers should follow to register non-notified medical devices.