An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply shall be assigned to Class A. (xv) Medical devices incorporating medicinal products (a) Subject to clause (b), a medical device shall be assigned to Class D, if it incorporates as an integral part a substance which, — (1) if used separately, may be considered to be a medicinal product; and (2) is liable to act on a human body with an action ancillary to that of the medical device. (b) A medical device referred to in clause (a) shall be assigned to Class B, if the incorporated substance is a medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder. (xvi) Medical devices incorporating animal or human cells, tissues or derivatives (a) Subject to clause (b), a medical device shall be assigned to Class D, if it is manufactured from or incorporates, — (1) cells, tissues or derivatives of cells or tissues, or any combination thereof, of animal or human origin, which are or have been rendered non-viable; or (2) cells, tissues or derivatives of cells or tissues, or any combination thereof, of microbial or recombinant origin. (b) A medical device referred to in clause (a) shall be assigned to Class A, if it is manufactured from or incorporates non-viable animal tissues, or their derivatives, that come in contact with intact skin only. (xvii) Medical devices for sterilization or disinfection (a) Subject to clause (b), a medical device shall be assigned to Class C, if it is intended to be used specifically for, — Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 86 of 248 (1) the sterilization of any other medical device; (2) the end-point disinfection of any other medical device; or (3) the disinfection, cleaning, rinsing or hydration of contact lenses. (b) A medical device shall be assigned to Class B, if it is intended for the.1 disinfection of any other medical device before the latter is sterilized or undergoes end-point disinfection: PROVIDED, that "end-point disinfection" means the disinfection of a medical device immediately before its use by or on a patient.