Public comments invited on draft amendments to Medical Device Rules, 2017; proposes requirement of registration to sell/ distribute, stock, exhibit medical devices; last date for submission of comments: 26th March, 2022

(1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.

(1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution or registration certificate in Form-42 under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.

(1) Subject to the provisions of these rules, Part VI relating to “Sale of Drugs Other than Homeopathic Medicines” of the Drugs and Cosmetics Rules, 1945, shall be applicable mutatis mutandis in respect of sale of medical devices.

(2) The licence granted or renewed under Part VI of the Drugs and Cosmetics Rules, 1945 for sale of drugs, prior to commencement of these rules, shall be deemed to continue to be valid for the purpose of sale of medical devices.

(1) Subject to the provisions of these rules, Part VI relating to “Sale of Drugs Other than Homeopathic Medicines” of the Drugs and Cosmetics Rules, 1945, shall be applicable mutatis mutandis in respect of sale of medical devices.

(1)(A) Notwithstanding anything contained in sub-rule(1), any person intends to sale medical devices exclusively as referred in clause (zb) of rule 3 shall obtain registration certificate as provided hereinafter in these rules.

(2) The licence granted or renewed under Part VI of the Drugs and Cosmetics Rules, 1945 for sale of drugs, prior to commencement of these rules, shall be deemed to continue to be valid for the purpose of sale of medical devices.

87(A) Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1) 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.

(2) 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 for grant of Registration Certificate to sell, stock, exhibit or offer for sale or distribution to the State Licensing Authority.

(3) The application made under sub-rule (2), shall be accompanied with

i. a fees prescribed in Second Schedule of the said rules;

ii. Self certificate of compliance with respect to Good Distribution Compliance;

iii. Details of the applicant/firm including its constitution, along with ID proof viz: Aadhar card, PAN card;

iv. Documentary evidence in respect of ownership or occupancy on rental of the premises;

v. 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.

vi. Brief description on other activities carried out by applicant,

vii: storage of drugs, medical items, food products, stationeries etc or any other activities carried out by applicant in the said premises. vii. The application made under sub-rule (2), shall be accompanied with an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.

(4) 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 MD-42, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days from the date, the application is made under sub-rule (2).

(5) If the application for grant of Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such appeal.

87(B) Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

i.The Registration Certificate shall be displayed at a prominent place in the premises visible to the public.

ii. The Registration Certificate holder shall provide adequate space, proper storage condition for storage of the Medical Devices.

iii. The Registration Certificate holder shall maintain required temperature and lighting as per requirements of such Medical Devices.

iv. The Medical Devices shall be purchased only from Importer or licensed manufacturer or registered/licenced entity under said rules.

v. Separate records, in 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/importers, Batch Number/Lot Number, Expiry Date shall be maintained. Such records shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18 of the said rules, who may, if necessary, make enquiries about purchases and sale of the Medical devices and may also take samples for testing.

vi. All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.

vii. The Registration Certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his/her observations and defects noticed.

87(C) Validity of registration certificate.— (1) 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 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.

87(D) Suspension and cancellation of Registration Certificate.—

(1) Where the Registration Certificate holder, contravenes any provision of the Act and the said rules, the State Licensing Authority, shall, after giving the Registration Certificate holder an opportunity to show cause as to why such an order should not be passed, shall by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or cancel the Registration Certificate.

(2) A Registration Certificate holder whose Registration Certificate has been suspended or cancelled by the State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government or Authority designated by the State Government, and the State Government or Authority designated by the State Government , shall after giving the Registration holder an opportunity of being heard, confirm, reverse or modify such order, with reasons to be recorded in writing.

Further, the Ministry has inserted provisions pertaining to-

1. Registration Certificate to sell, stock, exhibit or distribute a medical device including in vitro diagnostic medical device;

2. Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device;

3. Validity of registration certificate;

4. Suspension and cancellation of Registration Certificate;