Unannounced inspection by State Licensing Authority The State Licensing Authority shall, in cases where licence has been granted for manufacturing Class A and Class B medical devices under rule 20, cause an inspection of the manufacturing site to be carried out by a Medical Device Officer on a random basis and such inspection shall not be less than two per cent, of the total audits carried out by Notified Bodies within that State for that class of medical device. 29. Validity of licence (1) A licence or loan licence issued in Form MD-5, Form MD-6, Form MD-9 or Form MD-10 shall remain valid in perpetuity, subject to payment of licence retention fee as specified in the Second Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority or the Central Licensing Authority, as the case may be. (2) If the licence holder fails to pay the required licence retention fee on or before due date as referred to in sub-rule (1), the licence holder shall, in addition to the licence retention fee, be liable to pay a late fee calculated at the rate of two per cent, of the licence retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have been cancelled. 30. Suspension and cancellation of licence (1) Where the licensee contravenes any provision of the Act and these rules, the State Licensing Authority or the Central Licensing Authority, as the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 32 of 248 case may be, shall, after giving the licensee an opportunity to show cause as to why such an order should not be passed, shall by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or cancel the licence or loan licence. (2) A licensee whose licence or loan licence has been suspended or cancelled by the State Licensing Authority or the Central Licensing Authority, as the case may be, under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government or the Central Government, as the case may be, and the State Government or the Central Government, shall after giving the licensee an opportunity of being heard, confirm, reverse or modify such order. (3) The State Licensing Authority or the Central Licensing Authority, as the case may be, may revoke suspension order issued under sub-rule (2) for reasons to be recorded in writing. (4) Orders of suspension issued or revoked; or cancellation of licence shall be duly published on the concerned websites of the State Licensing Authority or the Central Licensing Authority, as the case may be. 31.Test licence to manufacture for test, evaluation, clinical investigations, etc. (1) Small quantity of Class A 17[(other than non-sterile and nonmeasuring)] or Class B or Class C or Class D of medical devices may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be made in Form MD-12 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule. (2) The application made under sub-rule (1) shall also be accompanied with the following documents, namely:— (a) brief description of the medical device including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 33 of 248 (b) list of equipment, instruments; (c) list of qualified personnel; (d) copy of manufacturing licence issued under these rules, if any; (e) approval letter authorising to undertake research and development activities issued by any Government organisation, if any. (3) The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application is made under sub-rule (1). (4) The licensee shall maintain a record of the details of quantity of the product manufactured under test licence. (5) A licence granted under sub-rule (3) shall, unless cancelled earlier, remain in force for a period of three years from the date of its issuance.