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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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