Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices
Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
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DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining Of Physical Support
Drugs and Cosmetics Act, 1940, and Rules regulates all new medical device’s safety, quality, and performance. The Central Government has notified the new Medical Devices Rules, 2017 vide G.S.R. 78E dated January...
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The Drugs and Cosmetics Act, 1940, and Rules regulate all medical devices' safety, quality, and performance. MoHFW (Ministry of Health and Family Welfare's) has issued notification vide G.S.R. 102 (E) dated 11.02.2021,...
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The Central Drugs Standards Control Organization (CDSCO) has recently released a notification on 26th July 2021 for the classification of medical devices used in the Dermatological and Plastic Surgery under the provisions...
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The Drugs and Cosmetics Act, 1940, and Rules regulate the safety, quality, and performance of all medical devices. The Central Government has notified Medical Devices Rules, 2017 vide G.S.R. 78E dated January...
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Regulations for the import or manufacture of medical devices The Ministry of Health & Family Welfare, Government of India, has notified the list of equipment or devices which will be regulated as...
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CDSCO has designated the National Institute of Biologicals (NIB), Noida, as Central Medical Device Testing Laboratory as per rule 19 of Medical Device Rules, 2017 released on 1st June 2018.NIB performs tests...