(v) "intended use" means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling or in the document containing instructions for use 1 [or electronic instructions for use] of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority; (w) "invasive device" means a device which, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body; (x) "investigational medical device" in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause (zb), — (i) which does not have its predicate device as defined in clause (zm); or (ii) which is licensed under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule 36 and claims for new intended use or new population or new material or major design change, and is being assessed for safety or performance or effectiveness in a clinical investigation; (y) "licence" means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19, as the case may be; (z) "loan licence" means a licence issued for manufacturing a medical device by the State Licensing Authority or the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other licensee for manufacturing the same medical device as manufactured by the licensee at that site; (za) "long term use" means intended continuous use of a medical device for more than thirty days; (zb) "medical device" means, — (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India and blood component collection bag with or without anticoagulant covered under sub-clause (i); (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii);