Definitions In these rules, unless the context otherwise requires, — (a) "academic clinical study" means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population; (b) "Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940); (c) "active diagnostic medical device" means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity; (d) "active medical device" means a medical device, the operation of which depends on a source of electrical energy or any other source of energy other than the energy generated by human or animal body or gravity; (e) "active therapeutic medical device" means any active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury or handicap; (f) "authorised agent" means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India;