New Delhi, the 30th September, 2022 G.S.R.754(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was
published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 104(E), dated the 9 th February, 2022, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of forty-five days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 10 th February, 2022; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:—
Paragraph 1
1. (i) These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022. (ii) These rules shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. In the Medical Devices Rules, 2017(hereinafter to be referred as the said rules), in rule 34, in sub-rule (1), after the words “wholesale licence for sale or distribution”, the words, letters and figure “or registration certificate in Form MD-42” shall be inserted.
Paragraph 3
3. In the said rules, in rule 87, after sub-rule (1), the following sub-rule shall be inserted, namely:— “(1A) Any person not holding licence under sub-rule (1) and intends to sell medical devices exclusively as referred to in clause (zb) of rule 3, shall obtain registration certificate as provided in these rules.”.
Paragraph 4
4. In the said rules, after rule 87, the following rules shall be inserted, namely:— “87A. 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 under 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 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution. (3) The application made under sub-rule (2) shall be accompanied with (i) a fees specified in Second Schedule; (ii) self certificate of compliance with respect to Good Distribution Compliance; (iii) details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or 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, who shall possess the following educational qualification and experience, namely:— (a) hold a degree from a recognized University/Institution; or (b) is a registered pharmacist; or (c) has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with sale of medical devices; (vi) brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and (vii) 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. 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 appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing. 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (7) 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. (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. 87C. 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, 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. 87D. Suspension and cancellation of Registration Certificate.— (1) 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 as to why such an order should not be passed, 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, as the case may be, 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 and 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.”.
Paragraph 5
5. In the said rules, in rule 88, in sub-rule (1), after the words “retail or wholesale”, the words, letters and figures “or registration certificate in Form MD-42” shall be inserted.
Paragraph 6
6. In the said rules, in the Second Schedule,— (a) in the provisions reference portion, after the figures and brackets “64(1), 81(1), 84,” and before the figure “91”, the following figures, letters and brackets shall be inserted, namely:— “87A(3), 87C(1) and”; (b) in the table, after serial number 51 and the entries relating thereto, the following serial numbers and entries shall be inserted, namely:— Sr. No. Rule Subject In rupees (INR) except where specified in dollars ($) (1) (2) (3) (4) “52. 87A(3) Registration certificate for sale of medical devices 3000 53. 87C(1) Retention fee for registration certificate for sale of medical devices 3000”
Paragraph 7
7. In the said rules, in the Fourth Schedule, in Part I, in the format of application of Power of Attorney for issuance of import licence, in paragraph 1, after the words “or manufacturing licence”, the words “or registration certificate” shall be inserted.
Paragraph 8
8. In the said rules, in the Appendix,— (a) after Form MD-40, the following Forms shall be inserted, namely:— “Form MD-41 [See sub-rule (2) of rule 87A] APPLICATION FOR GRANT OF REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE OR DISTRIBUTE A MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC MEDICAL DEVICE 1. Name of applicant: 2. Address of the premises to be registered: 3. Contact details of applicant including telephone number, mobile number, fax number and email id: 4. Nature and constitution of applicant: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust, other to be specified) 5. Name, qualification and experience of competent person appointed: 6. Fee paid on _______________ Rs____________________ receipt/challan/transaction Id___________. 7. I have enclosed the documents as specified in the sub-rule (3) of rule 87A of the Medical Devices Rules, 2017. Place: __________ Date: ___________ Name, designation & signature of Director/Proprietor/Partner Form MD-42 [See sub-rule(4) of rule 87A and sub-rule (1) of rule 87C] REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE OR DISTRIBUTE A MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC MEDICAL DEVICE Registration No.: ................... 1. M/s, .......................................................................................(Name of the firm) situated at ........................................................................(full address with telephone and e-mail) has been registered to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device under the Medical Devices Rules, 2017. 2. Name and qualification of competent person: 3. This registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017. Place: __________ Date: ___________ State Licensing Authority Form MD-43 [See sub-rule (8) of rule 87B] Form in which the Inspection Book shall be maintained (A) The cover of the inspection book shall contain the following particulars, namely:— 1. The name and address of the registration certificate holder __________ ________________________________________. 2. Registration certificate number______________________________. (B) (i) The pages of the inspection book shall be serially numbered and duly stamped by the State Licensing Authority*. The pages, other than the first and the last pages, shall have the following particulars:— Name and designation of the Medical Device Officer who inspected the premises: Date of inspection ___________________________________________ Observations of the Medical Device Officer _______________________ Signature of the Medical Device Officer 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (ii) The first and last pages of the inspection book shall be endorsed by the State Licensing Authority with the following words, namely:— Inspection book maintained by M/s _______________________situated at ______________ for Registration number ______________ in Form MD-43______________ under the Medical Devices Rules, 2017. State Licensing Authority Notes: (i) Printed copy of the inspection book may be obtained by the licencee from the Licensing Authority on payment of fee as may be specified by the concerned Licensing Authority from time-to-time. (ii) The inspection book shall be maintained at the premises of the licencee. (iii) The original copy of observations made by the Medical Device Officer shall be maintained in the premises of the licencee and duplicate copy shall be sent to the State Licensing Authority. The triplicate copy shall be taken as record by the Medical Device Officer.”; (b) in Form MD-14, in paragraph 3, in sub-para (ii), after the words “manufacturing licence”, the words “or registration certificate” shall be inserted; (c) in Form MD-15, in paragraph 1, after the words “manufacturing licence”, the words “or registration certificate” shall be inserted; (d) in Form MD-26, in paragraph 3, in sub-paragraph (ii), after the words “manufacturing licence”, the words “or registration certificate” shall be inserted; (e) in Form MD-28, in paragraph 3, sub-paragraph (ii), after the words “manufacturing licence”, the words “or registration certificate” shall be inserted.”.
[F. No. X.11014/15/2021-DR] DR. MANDEEP K. BHANDARI, Jt. Secy. Note: The Medical Devices Rules, 2017 was published in the Gazette of India, Extraordinary, Part II, section 3, sub- section (i) vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 450(E), dated the 15 th June, 2022.