The Ministry of Health and Family Welfare on 30th September 2022, published the Medical Devices (Fifth Amendment) Rules, 2022 through which it has notified a new rule, 87A which deals with Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.
As per the new rule, the State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas as may be specified. Any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution.
Once the registration certificate is granted under rule 87A it shall be displayed at a prominent place in the premises visible to the public. The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.
The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices. The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity. Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained.
Further all registers and records, shall be preserved for a period of not less than two years from the last entry, therein and the registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.
A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority:
Provided that, if the registration certificate holder fails to pay the required registration certificate retention fee on or before due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within six months: Provided further that in the event of non-payment of such fee within the period referred to in the first proviso, the registration certificate shall be deemed to have been cancelled.
