MD-42

The Medical Devices (Fifth Amendment) Rules, 2022, which amend the Medical Devices Rules, 2017, were notified by the Central Government on 30th September 2022, following consultation with the Drugs Technical Advisory Board. According to the rules, any person who does not have a license but plans to sell medical device exclusively must obtain a registration certificate in MD-42. The application is filed in MD-41 to State Licensing Authority to get medical device registration certificate on Form MD-42. The registration process can become complex when it comes to rules and regulations.

The Medical Devices (Fifth Amendment) Rules, 2022 have laid down certain conditions for obtaining the registration certificate, which is as follows-

1. 1 )The registration certificate, granted under rule 87A, must be displayed in a prominent space in the workplace, which is easily visible to the public.
2. 2 )The certificate holder must provide enough space and proper conditions for storing the medical devices.
3. 3 )The certificate holder must maintain the requisite temperature and lighting according to the requirements of the medical device.
4. 4 )The medical devices shall be purchased from a licensed manufacturer or importer only.
5. 5 )Separate records in the form of registers, invoices or electronic details such as software for the sale and purchases of a medical device shall be maintained. The details such as name, quantity, name and address of the manufacturer or importer, batch number or lot number and manufacturer expiry date must also be visible on the device.
6. 6 )The Medical Device Officer can inspect and enquire about purchases and sales of medical devices, and he can also take samples for tests.
7. 7 )All the registers and records shall be kept safe for a minimum of two years from the last entry.
8. 8 )The registration holder must maintain an inspection book in Form MD-43 to allow the Medical Device Officer to note his observations and feedback on the inspection.