2023-05-09T04:42:38
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.
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