2023-06-08T05:19:02
IMPORT OF MEDICAL DEVICES
34. Application for grant of import licence
(1) An authorised agent having licence to manufacture for sale or
distribution or wholesale licence for sale or distribution 18[or registration
certificate in Form MD-42] under these rules, shall make an application for
grant of import licence for medical device to the Central Licensing Authority
through an identified online portal of the Ministry of Health and Family
Welfare in the Central Government in Form MD-14 for obtaining a licence.
(2) The application under sub-rule (1) shall be accompanied with the
fee as specified in the Second Schedule along with respective documents as
specified in the Fourth Schedule:
PROVIDED that any change in the documents submitted at the time of
application and prior to grant of licence shall be informed, in writing, to the
Central Licensing Authority.
(3) Where the Central Licensing Authority, has reason to believe that
the quality of the medical device is compromised, and decides to subject it to
evaluation, test or examination, the authorised agent shall pay a fee for such
evaluation, test or examination, to the testing laboratory as specified by the
Central Licensing Authority
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 35 of 248
(4) Any subsequent application for, —
(i) grant of licence for additional manufacturing site for the same
medical device by the same authorised agent shall be accompanied
with a fee and documents as referred in sub-rule (2);
(ii) licence for additional medical device manufactured at the same
manufacturing site shall be made by the same authorised agent
accompanied with fee as specified in the Second Schedule and
respective documents as specified in the Fourth Schedule.
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