Post Marketing Clinical Investigation: Post marketing clinical investigation is the study other than surveillance performed after marketing approval has been given to the medical device in relation to the approved indication. This investigation may not be considered necessary at the time of medical device approval but may be required by the Central Licensing Authority for optimizing the intended use of the medical Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. device. Post Marketing Clinical investigation includes additional drug device interaction, safety studies, investigation designed to support use under the approved indication e.g. mortality or morbidity studies, etc.
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