The application for import of any medical device or in vitro diagnostic medical device for the purpose of clinical investigations, test, evaluation, examination, demonstration or training shall be made in Form MD-16 to the Central Licensing Authority along with a fee as specified in the Second Schedule. The Central Licensing Authority may grant a test licence in Form MD-17 along with the quantity, or may reject the application within 30 days. The licence is valid for three years.
The consignment of medical device should be accompanied by an invoice or statement showing the name and quantity of the medical device. The licencee should maintain the record of the activities undertaken including the name of manufacturer, quantity imported and date of import. The medical device should be used exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training. The devices which are not used should be exported or destroyed under intimation to the Central Licensing Authority.
If the licencee fails to comply with any provisions of these rules, the Central Licensing Authority after giving a show cause may cancel the license. The licencee may appeal against the order within 45 days to the Central Government.
Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient
The application for import of small quantity of any medical device, the import of which is not allowed, but approved in the country of origin, shall be made in Form MD-18 to the Central Licensing Authority along with a fee as specified in the Second Schedule and required documents. The application should be made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution for treatment of a patient with life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need. The Central Licensing Authority may grant the licence in Form MD-19 along with the quantity.
The consignment of medical device should be accompanied by an invoice or statement showing the name and quantity of the medical device. The licencee should maintain the record of the activities undertaken including the name of manufacturer, quantity imported, date of import, name and address of the patient and diagnosis. The medical device should be used exclusively for the treatment of the patient. The medical device officer authorized by the Central Licensing Authority may inspect the premises and records and investigate the manner in which the medical devices are used and to draw the samples, if required.
Import of medical device for personal use
Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use if the medical device forms part of a personal baggage, as declared to the customs authorities if required, in a quantity prescribed by the registered medical practitioner along with an invoice showing its name and quantity.
If it does not forms a part of a bona fide personal luggage, then an application should be made in Form MD-20 along with documents showing it is meant for personal use and a prescription of the registered medical practitioner. The permission is granted in Form MD-21 by the Central Licensing Authority or the application is rejected within 7 days, with reasons in writing. During import, the medical device should be declared to the customs authorities if they so direct and should be accompanied by an invoice showing its name and quantity.