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2023-09-02T09:21:00
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xiii) Active diagnostic medical devices(a) Subject to clauses (b) and (c), an active diagnostic medical devic

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. (3) for the direct diagnosis or monitoring of vital physiological processes.

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