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If the application for grant of licence or loan licence to manufacture
for sale or for distribution is rejected under sub-rule (4) or sub-rule (6), the
aggrieved person may file 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,
be disposed of within a period of sixty days.
(8) Where the Central Licensing Authority or the State Licensing
Authority has reason to believe or it has been alleged or suspected that the
medical device does not conform to the standards of quality, or the provisions
of the Fifth Schedule are not complied with, the State Licensing Authority, in
case of Class A 16[(other than non-sterile and non-measuring)] or Class B
medical device, or the Central Licensing Authority, in case of any Class of
medical device, may direct a team of officers referred to in rule 23 to cause
inspection of licensed manufacturing site.
21. Application for manufacturing Class C or Class D devices
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 26 of 248
(1) An application shall be made to the Central Licensing Authority
through an identified online portal of the Central Government for licence or
loan licence to manufacture for sale or for distribution, as the case may be, of
Class C or Class D medical device in Form MD-7 or Form MD-8,
respectively.
(2) The application in Form MD-7 or Form MD-8 referred to in subrule (1) relating to Class C or Class D medical device, as the case may be,
shall be accompanied with a fee as specified in the Second Schedule along
with documents as specified in clause (ii) of Part II of the Fourth Schedule.
(3) The Central Licensing Authority may, wherever required, in case of
Class C or Class D medical devices, use the services of any expert in the
relevant field for scrutiny of application and other technical documents.
(4) The scrutiny referred to in sub-rule (3) shall be completed by the
Central Licensing Authority within a period of forty-five days from the date
of online submission of application.
(5) In case, where the documents are found to be complete and in order,
the Central Licensing Authority shall cause an inspection of the
manufacturing site carried out under rule 23 by a team of officers
accompanied by such experts, as may be considered necessary.
(6) The Central Licensing Authority may, where required, avail the
services of a Notified Body referred to in sub-rule (4) of rule 13 for
inspecting the manufacturing site of Class C and Class D medical devices.
(7) In case, where the documents furnished with the application referred
to in sub-rule (1) are not found to be complete and in order, the Central
Licensing Authority shall reject the application and inform the applicant of
the reasons for such rejection electronically.
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