The Medical Devices ( Draft Amendment) Rules, 2022.

The Ministry of Health and Family Welfare on 9^th February 2022 has notified the Medical Devices (Draft Amendment) Rules, 2022 to further amend the Medical Device Rules, 2017.

Through this amendment, it has been notified that any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic shall obtain registration certificate under rule 87(A).

The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing Registration Certificate in this Part for such areas as may be specified. The Application shall made in Form MD-41 for grant of Registration Certificate to sell, stock, exhibit or offer for sale or distribution to the State Licensing Authority.

The Application shall be accompanied with

1. a fees prescribed in Second Schedule of the said rules;
2. Self certificate of compliance with respect to Good Distribution Compliance;
3. Details of the applicant/firm including its constitution, along with ID proof viz: Aadhar card, PAN card;
4. Documentary evidence in respect of ownership or occupancy on rental of the premises;
5. Details of competent technical staff under whose direction and supervision the sales activity of medical device shall be undertaken and such staff shall possess the following educational qualification and experience,—

(a) holds a degree of a recognized University; or

(b) is a registered Pharmacist; or

 (c) has passed intermediate examination or its equivalent examination from a recognized Board with the one-year experience in dealing with sale of Medical Devices.

The  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 as referred to in sub-rule(1), 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 percent. 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 during that period, the Registration Certificate shall be deemed to have been cancelled.