The Ministry of Health & Family Welfare (MoHFW) notified Medical Devices (Fifth Amendment) Rules, 2022 on 30th September 2022.
Medical Device Rules, 2017 is the regulating provisions related to Medical Devices, Drugs and I.V.D.s.
The following provisions have been inserted for the registration process:
Rule 87A: Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device which provides The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate.
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.
The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate in Form MD42.
Rule 87B: Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device:
(1) The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.
(2) The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.
(3) The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.
(4) The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity.
(5) 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.
(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer
(7) All registers and records mentioned under these rules,
(8) 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.
Rule 87C. Validity of registration certificate provides that a registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified.
Rule 87D. Suspension and cancellation of Registration Certificate: Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause may cancel the registration certificate.
Therefore, any person who does not have a licence but plans to sell medical device must obtain a the mentioned registration certificate.
