Gujarat FDCA Issuing Registration Certificate to Medical Device Manufacturers.

Gujarat FDCA news for Medical Device Manufacturers.

The Gujarat Food and Drug Control Administration has begun issuing medical device Registration Certificate (RC) (MD-42) to medical device makers in the state as part of a smooth transition to the new medical device regime. It recently gave RCs to 30 members of the Ophthalmic Association, Ahmedabad, as part of a workshop organized on the new Medical Device (MD) Rules- 2017. The revised (MD) Rules 2017 are still in transition and will not be fully implemented until October 1, 2023. As per the new rules 2017, Non-Notified Class A and B medical devices will require an Import License by October 1, 2022, while Non-Notified Class C and D medical devices will require one by October 1, 2023, and hence the registration certificates are required. DCGI issued a notification on September 30,2022, according to that medical device Registration certificate (MD-42) is required for the vendors who are engaged in medical device sector.  

The central government Gazette notification GSR 754 (E), notified that to sell stock, exhibit or offer for sale or distribute medical device including IVD a registration certificate form MD-42 is mandatory if the firm is not holding license under the rule 87 of MDR 2017. As a CDSCO registration consultant we are assisting medical device manufacturers to obtain the manufacturing license and medical device registration certificate. For any assistance or queries related to CDSCO licensure feel free to contact us. 

The State of Gujarat is experiencing exponential growth in the field of pharmaceutical industry and medical devices in the country due to Atmanirbhar Bharat, make in India campaign,” said Dr HG Koshia, Gujarat FDCA Commissioner. There is currently no recognized regulatory structure. According to government notifications, it will take another two years to implement. The government has set an 18-month period for voluntary registration of medical devices commencing April 1, 2020, following which Class A and Class B medical devices would have 12 months to complete the licensing process, while Class C and Class D will have another 12 months. The new medical device laws will not be implemented until October 2023.Manufacturers will be required to obtain registration certificates until time regulations are in place, which is expected to be in October 2023.