Inspection of overseas manufacturing site (1) On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose. (2) 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 under sub-rule (1). 36. Grant of import licence (1) After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application. (2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty-five days and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto within a period of ninety days from the date of appeal. (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, 19[United Kingdom or the United States of America], a Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 36 of 248 licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation. (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in case of Class A 20[(other than nonsterile and non-measuring)] or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished. (6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any class of such medical device shall be granted without such permission.