2023-05-09T05:00:02
Inspection report
After completion of inspection as referred to in rule 23, the inspection
team shall forward a descriptive report containing findings on each aspect of
inspection along with the recommendations to the Central Licensing
Authority, through online portal of the: Ministry of Health and Family
Welfare in the Central Government and forward a copy of the same to the
applicant.
25. Grant of licence or loan licence to manufacture for sale or for
distribution
(1) If the Central Licensing Authority, after receipt of the report as
referred to in rule 24, and such further enquiry, if any, as may be considered
necessary, is satisfied that the requirements of these rules have been
complied, that Authority shall grant a licence in Form MD-9, or loan licence
in Form MD-10 or may reject the application for reasons to be recorded in
writing, within a period of forty-five days from the date the inspection report
has been received.
(2) If the application for grant of licence or loan licence to manufacture
for sale or for distribution is rejected under sub-rule (1), the aggrieved person
may file an appeal before the Central 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, be disposed of within a
period of sixty days.
(3) In case, a licensee or loan licensee intends to manufacture additional
medical devices in the licensed manufacturing site, the manufacturer shall
make an application for grant of permission to manufacture such medical
devices to the Central Licensing Authority or State Licensing Authority, as
the case may be, along with the fee as specified in the Second Schedule and
the documents as referred to in rule 20 or rule 21, as the case may be.
(4) In case of investigational medical device or new in vitro diagnostic
medical device, the applicant shall obtain prior permission in Form MD-27 or
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 29 of 248
Form MD-29 from the Central Licensing Authority and no licence to
manufacture any class of such medical device shall be granted without such
permission.
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