Description: ICAC (IC) mark: Indian Conformity Assessment Certificate (ICAC) mark
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India has finalized the guidelines to the manufacture, import and sale of medical devices under Schedule M III.
The Drugs Technical Advisory Board (DTAB) which provides technical guidance to the Central Drugs Standard Control Organization under the ministry of Health and Family Welfare has submitted the final draft of the guidelines on medical devices.
The medical devices and equipment are currently notified as drugs are regulated under the Drugs & Cosmetics Act and Rules. However, the guidelines will apply to inspections and other requirements Schedule M III.