(1) Save as provided in sub-rule (4) of rule 5, an application shall be made to the State Licensing Authority through an identified online portal of the Central Government for licence to manufacture for sale or for distribution of Class A or Class B medical devices in Form MD3.
(2) An application shall be made by the applicant to the Central Licensing Authority through an identified online portal of the Central Government for licence to manufacture for sale or for distribution of Class C or Class D medical device in Form MD4.
(3) Where any manufacturer intends to manufacture Class C or Class D medical device along with Class A or Class B medical device, an application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence to manufacture for sale or for distribution in Form MD4.
(4) The application in Form MD4 referred in sub-rule (2), relating to Class A medical devices referred under sub-rule (4) of rule 5, shall be accompanied with a 13 fee as specified in the Second Schedule along with documents specified in clause
(i) of Part II of the Fourth Schedule.
(5) The application in Form MD3 or Form MD4 referred in sub-rule (1), (2) and
(3), relating to Class B, 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.
(6) The Central Licensing Authority may, wherever required, in case of Class C or Class D medical device, use the services of experts for matters relating to inspection or review of the documents:
Provided that the powers and functions under this rule shall be exercised by the Central Licensing Authority till such time the Central Government is satisfied that the requisite technical competence has been acquired by the State Licensing Authority.
Loan licence to manufacture for sale and distribution.