(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 the Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD16 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 the import licence for treatment of patient in Form MD17.
(3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose of treatment of patient declared in the application.
(4) The holder of licence shall maintain record of activities undertaken including the name of the manufacturer, quantity imported and used, date of import, name and address of the patient and diagnosis.
(5) The holder of 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 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 the import of larger quantity of medical devices for use by the patient.
22
(8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name and address of the manufacturer and the name and quantity of medical device.
Import of medical device for personal use.