2023-04-26T05:23:13
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.
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