2023-04-27T06:33:03
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
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 9th 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 10th 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:—
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.
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.
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.”.
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
[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 7
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 MD42, 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.”.
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.
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”
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.
8. In the said rules, in the Appendix, —
(a) after Form MD-40, the following Forms shall be inserted, namely:—
[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 9
“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/Partne
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