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With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules. Out of four Classes of medical devices from Class A to Class D, DCGI will be the direct licensing authority for Class C and Class D devices ...
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Medical devices under the Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI.
Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings.
Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR . [2]
Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union; Medical Device Regulation Act of 1976 in the United States