Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient (1) Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by documents required and the fee as specified in the Second Schedule. (2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant import licence for treatment of patient in Form MD-19. (3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose of treatment of the patient referred to in sub-rule (1). (4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of import, name and address of the patient and diagnosis. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 41 of 248 (5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect the premises and relevant records and investigate the manner in which the medical device is being used and to take, if required, samples thereof. (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking into account the recommendation of the hospital concerned for treatment of patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need. (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import of larger quantity of medical devices for use by the patient. (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name and quantity of medical device.