2023-09-02T09:24:35
(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.
Have a question? Ask here!
Required fields are marked *