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 (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.
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