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The Gujarat Food and Drug Control Administration (FDCA) has started issuing Registration Certificate (RC) (MD-42) to medical device manufacturers in the state as part of the transitioning to new medical device regime in a smooth way.
It recently issued RCs to 30 members of the Ophthalmic Association, Ahmedabad as part of the workshop organized on new Medical Device (MD) Rules- 2017. The new (MD) Rules 2017 is still in transition period and will take time of another two years till October 1, 2023 to be implemented completely.
As per new Medical Device (MD) Rules, 2017, RC is required as Non-Notified Class A and B medical devices must require an Import License by October 1, 2022 while Non-Notified Class C and D medical devices must have one by October 1, 2023. Some products, called notified medical devices, required a more extensive registration requiring a device master file, called an import license.
As per a Drugs Controller General of India (DCGI) notification dated September 30, 2022, it is required to have RC (MD-42) for vendors engaged in the medical device sector.
The Central government vide Gazette notification GSR 754(E) dated September 30, 2022, has notified that to sell, stock, exhibit or offer for sale or distribute medical device including in vitro diagnostic (IVD) medical device, a Registration Certificate in form MD 42 is mandatory if the firm is not holding license under sub Rule (1) of Rule 87 of Medical Devices Rules 2017.
As of today there are 615 own medical devices (in Form β MD -5) licensees in Gujarat, 55 medical devices loan licensees (in Form β MD -6) with a total number of 670 licensees in the state. Sales licenses in Gujarat state in (in Form MD -42) are 114 as of today.
βThe Gujarat FDCA in collaboration with Ahmedabad Optical Association (AoA) did on-the-spot registration for vendors engaged in the medical device sector in the Ophthalmic segment in Ahmedabad and surrounding districts. RC (MD-42) was awarded to them at Ahmedabad Management Association (AMA) office as part of Good Governance Week. 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,β said Dr HG Koshia, Gujarat FDCA Commissioner.
There is no established regulatory regime today. It will take another two years to get implemented based on government notifications. Government has notified 18 months for voluntary registration of medical devices with effect from April 1, 2020 following which Class A and Class B medical devices will get time for the licensing process for 12 months and another 12 months for Class C and Class D. This entire process will take time until October 2023 for the new medical device regulations to get implemented.
According to experts until the time regulations are not in place which will most likely come into being by October 2023, the manufacturers will have to secure registration certificates.
Y G Darji, Assistant Commissioner, Ahmedabad Division (Division -2), A A Raddia, Assistant Commissioner, Ahmedabad Division-1, V D Dobariya, Assistant Commissioner, Ahmedabad Rural, M P Gadhvi (Assistant Commissioner, Medical Devices, Gandhinagar), Yogeshbhai Parikh (Vice President, Gujarat Chamber of Commerce and Industry) and Nareshbhai Choksi (President, Ahmedabad Optical Association) and their office bearers participated during the workshop.
Experts have also revealed that a large number of certificates of certification for quality management systems (QMS) as per international standard, ISO 13485, in medical devices are unauthentic or fake.
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