Applicability: The provisions of this Schedule shall be applicable to manufacturers of finished devices, in vitro diagnostic medical devices, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants. 3. Terms and definitions: 3.1 Active implantable medical device—Active medical device which is intended to be totally or partially introduced, surgically or medically, into the human or animal body or by medical intervention into a natural orifice and which is intended to remain after the procedure. 3.2 Active medical device—Medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human or animal body or gravity. 3.3 Advisory notice—Notice issued by the manufacturer, subsequent to delivery of the medical device and in vitro diagnostic medical devices, to provide supplementary information or to advise what action should be taken in or both in— (a) the use of a medical device and in vitro diagnostic medical devices; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 132 of 248 (b) the modification of a medical device and in vitro diagnostic medical devices; (c) the return of the medical device and in vitro diagnostic medical devices to the organization that supplied it; or (d) the destruction of a medical device and in vitro diagnostic medical devices.