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 these rules and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before grant of licence.