(1) "clinical investigation" means the systematic study of an investigation medical device in or on human participants to assess its safety, performance or effectiveness; (m) "clinical investigation plan" means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, w ...

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 Fa ...