Parameters for classification of medical devices (i) Non-invasive medical devices which come into contact with injured skin (a) A non-invasive medical device which comes into contact with injured skin shall be assigned to Class A, if it is intended to be used as a mechanical barrier, for compression or for absorption of exudates only, for wounds which have not breached the dermis and can heal by primary intention; (b) Subject to clause (c), a non-invasive medical device which comes into contact with injured skin shall be assigned to Class B, if it is intended to be used principally with wounds which have breached the dermis, or is principally intended for the management of the microenvironment of a wound; (c) a non-invasive medical device which comes into contact with injured skin shall be assigned to Class C, if it is intended to be used principally with wounds which have breached the dermis and cannot heal by primary intention. (ii) Non-invasive medical devices for channeling or storing substances (a) Subject to clauses (b) and (c), a non-invasive medical device shall be assigned to Class A, if it is intended for channeling or storing body liquids or tissues or liquids or gases for the purpose of eventual infusion, administration or introduction into a human body; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (b) A non-invasive medical device referred to in clause (a) shall be assigned to Class B, if it is intended to be connected to an active medical device which is in Class B, C or D or for channeling blood or storing or channeling other body liquids or storing organs, parts of organs or body tissues: PROVIDED, that the circumstances when a non-invasive medical device is connected to an active medical device include circumstances where the safety and performance of the active medical device is influenced by the non-invasive medical device, or vice versa; or (c) A non-invasive medical device referred to in clause (a) shall be assigned to Class C, if it is a blood bag that does not incorporate a medicinal product. (iii) Non-invasive medical devices for modifying compositions of substances (a) Subject to clause (b), a non-invasive medical device shall be assigned to Class C, if it is intended for modifying the biological or the chemical composition of blood or other body liquids or other liquids intended for infusion into the body. (b) A non-invasive medical device as referred to in clause (a) shall be assigned to Class B, if the intended modification is carried out by filtration, centrifuging or any exchange of gas or of heat. (iv) Other non-invasive medical devices A non-invasive medical device to which sub-paragraphs (i), (ii) and (iii) do not apply shall be assigned to Class A, if it does not come into contact with a person or comes into contact with intact skin only. (v) Invasive (body orifice) medical devices for transient use (a) Subject to clause (b), an invasive (body orifice) medical device shall be assigned to Class A, if, — (1) it is intended for transient use; and (2) it is not intended to be connected to an active medical device; or Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (3) it is intended to be connected to a Class A medical device only. (b) An invasive (body orifice) medical device referred to in clause (a) shall be assigned to Class B, if, — (1) it is intended for use on the external surface of an eyeball; or (2) it is liable to be absorbed by the mucous membrane. (vi) Invasive (body orifice) medical devices for short term use (a) Subject to clause (b), an invasive (body orifice) medical device shall be assigned to Class B, if, — (1) it is intended for short term use; and (2) it is not intended to be connected to an active medical device; or (3) it is intended to be connected to a Class A medical device only. (b) An invasive (body orifice) medical device referred to in clause (a) shall be assigned to Class A, if, — (1) it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity; and (2) it is not liable to be absorbed by the mucous membrane. (vii) Invasive (body orifice) medical devices for long term use (a) Subject to clause (b), an invasive (body orifice) medical device shall be assigned to Class C, if it is intended for long term use and, not intended to be connected to an active medical device or it is to be connected to a Class A medical device only. (b) An invasive (body orifice) medical device referred to in clause (a) shall be assigned to Class B, if, — (1) it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity; and (2) it is not liable to be absorbed by the mucous membrane. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 81 of 248 (viii) Invasive (body orifice) medical devices for connection to active medical devices An invasive (body orifice) medical device shall be assigned to Class B, regardless of the duration of its use, if it is intended to be connected to an active medical device which is in Class B, C or D. (ix) Surgically invasive medical devices for transient use (a) Subject to clauses (b) to (g), a surgically invasive medical device intended for transient use shall be assigned to Class B. (b) Subject to clauses (c) to (g), a transient use surgically invasive medical device shall be assigned to Class A, if it is a reusable surgical instrument. (c) A transient use surgically invasive medical device shall be assigned to the same class as the active medical device to which it is intended to be connected. (d) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended for the supply of energy in the form of ionising radiation. (e) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended to have a biological effect or to be wholly or mainly absorbed by the human body. (f) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended for the administration of any medicinal product by means of a delivery system and such administration is done in a manner that is potentially hazardous. (g) A transient use surgically invasive medical device shall be assigned to Class D, if it is intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (x) Surgically invasive medical devices for short term use (a) Subject to clauses (b), (d) and (e), a surgically invasive medical device intended for short term use shall be assigned to Class B. (b) Subject to clause (c), a short term use surgically invasive medical device shall be assigned to Class C, if it is intended to undergo a chemical change in the body. (c) A short term use surgically invasive medical device referred to in clause (b) shall be assigned to Class B, if it is intended to be placed into any tooth. (d) A short term use surgically invasive medical device shall be assigned to Class C, if it is intended for the administration of any medicinal product or the supply of energy in the form of ionising radiation. (e) A short term use surgically invasive medical device shall be assigned to Class D, if it is intended to have a biological effect or to be wholly or mainly absorbed by the human body or to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.