(xiv) Other active medical devices 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.
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