Implantable medical devices and surgically invasive medical devices for long term use (a) Subject to clauses (b), (c) and (d), an implantable medical device or a surgically invasive medical device intended for long term use shall be assigned to Class C. (b) A long term use medical device shall be assigned to Class B, if it is intended to be placed into any tooth. (c) A long term use medical device shall be assigned to Class D, if it is intended, — (1) to be used in direct contact with the heart, the central circulatory system or the central nervous system; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 83 of 248 (2) to be life supporting or life sustaining; (3) to be an active medical device; (4) to be wholly or mainly absorbed by the human body; (5) for the administration of any medicinal product; or (6) to be a breast implant. (d) Subject to clause (b), a long term use medical device shall be assigned to Class D, if it is intended to undergo chemical change in the body. (xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for the administration or exchange of energy to or with a human body. (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or exchange of energy may be done in a potentially hazardous way (such as through the emission of ionizing radiation), taking into account the nature, density and site of application of the energy and the type of technology involved. (c) An active therapeutic medical device shall be assigned to Class C., if it is intended for the control or monitoring, or to be used to directly influence the performance, of a Class C active therapeutic device. (xiii) Active diagnostic medical devices (a) Subject to clauses (b) and (c), an active diagnostic medical device shall be assigned to Class B, if it is intended, — (1) to be used to supply energy which will be absorbed by the human body; (2) to be used to capture any image of the in vivo distribution of radio-pharmaceuticals; or Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 84 of 248 (3) for the direct diagnosis or monitoring of vital physiological processes. (b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared spectrum. (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended specifically for, — (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it could result in immediate danger to the patient (such as any variation in cardiac performance, respiration or activity of the central nervous system); or (2) diagnosing in a clinical situation where the patient is in immediate danger. (d) An active diagnostic medical device shall be assigned to Class C, if it is intended for the emission of ionising radiation and to be used in diagnostic or interventional radiology. (e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the control or monitoring, or to be used to directly influence the performance, of any active diagnostic medical device referred to in clause (d). (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body. (g) An active medical device referred to in clause (f) shall be assigned to Class C, if the administration or removal of the medicinal product, body liquid or other substance is done in a manner that is potentially hazardous, taking into account, — (1) the nature of the medicinal product, body liquid or substance; (2) the part of the body concerned; and (3) the mode and route of the administration or removal. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 85 of 248 (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. (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. (xviii) Medical devices for contraceptive use (a) Subject to clause (b), a medical device intended to be used for contraception or the prevention of the transmission of any sexually transmitted disease shall be assigned to Class C. (b) A medical device referred to in clause (a) shall be assigned to Class D, if it is an implantable medical device or an invasive medical device intended for long term use.