(1) The Central Licensing Authority shall have the powers to grant licence and perform other related functions for import of medical devices specified in subrule (1) and (2) of rule 5.
(2) An authorised agent having, licence to manufacture for sale or licence to sale by way of wholesale under these rules, shall make an application for import of such medical device to the Central Licensing Authority in Form MD12 for obtain a licence.
(3) The application under sub-rule (2) shall be accompanied with fee as specified in the Second Schedule along with documents as specified in the Part I, II, and III of the Fourth Schedule:
Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be notified to the Central Licensing Authority.
(4) (i) Any subsequent application for grant of licence of additional manufacturing site made by the same authorised agent shall be accompanied with a fee as referred in sub-rule (3);
(ii) Any subsequent application for licence of additional medical device made by the same authorised agent shall be accompanied with the fee as specified in the Second Schedule for each medical device;
(iii) In case of any subsequent application for grant of licence of different variants of already registered family is made by the same authorised agent, the additional fee as specified in the Second Schedule shall be paid for each variant.
(5) A single licence may be granted to an authorised agent in India in respect of one or more medical devices manufactured at one or more manufacturing sites.
(6) Where the Central Licensing Authority has a reasonable doubt about the quality of the medical device and decides to subject it to evaluation, test or examination, the fee as charged by concerned testing Centre shall be paid by the authorised agent for such evaluation, test or examination directly to the testing laboratory as specified by the Central Licensing Authority.
(7) Where the original licence is defaced, damaged or lost, the authorised agent may make an application accompanied with fee as specified under the Second Schedule for duplicate copy of such licence.
Inspection of overseas manufacturing site.
31. The Central Licensing Authority may cause an inspection of the overseas manufacturing site either by itself or by any other person to whom the power has been delegated for the purpose and the applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure required in connection with the visit to the overseas manufacturing site.
19 Grant of licence of medical device and manufacturing site for import.