Grant of licence or loan licence to manufacture for sale or for distribution (1) If the Central Licensing Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in writing, within a period of forty-five days from the date the inspection report has been received. (2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days. (3) In case, a licensee or loan licensee intends to manufacture additional medical devices in the licensed manufacturing site, the manufacturer shall make an application for grant of permission to manufacture such medical devices to the Central Licensing Authority or State Licensing Authority, as the case may be, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21, as the case may be. (4) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-27 or Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 29 of 248 Form MD-29 from the Central Licensing Authority and no licence to manufacture any class of such medical device shall be granted without such permission.