MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION 20. Application for manufacture for sale or for distribution of Class A 12 [(other than non-sterile and non-measuring)] or Class B medical device Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 24 of 248 (1) Any person who intends to manufacture a Class A 13[(other than non-sterile and non-measuring)] or Class B medical device including in intro diagnostic medical device shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority. (2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth Schedule. (3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with. (4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class A 14[(other than non-sterile and non-measuring)] medical devices in Form MD-5 or loan licence in Form MD6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within forty-five days from the date, the application is made under sub-rule (1): PROVIDED that, — (i) no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for sale or for distribution of Class A 15[(other than non-sterile and non-measuring)] medical device; and (ii) the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted by the State Licensing Authority. (5) Manufacturing site of the applicant, in respect of Class B device, shall conform to the requirements of Quality Management System as specified under the Fifth Schedule and applicable standards as specified under Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 25 of 248 these rules and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before grant of licence.