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complete procedure to meet

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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Wholesale Drug License

A wholesale drug license in Form 21B is a prerequisite for starting a business to sell or distribute drugs that include biologicals, in-vitro diagnostic kits, and medical devices. In India, the government...

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DCGI enlists new regulation for the classification of medical devices pertaining to Cardiovascular

The Drugs and Cosmetics Act of 1940, as well as the rules promulgated under it, govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules,...

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Why do we need import licenses for In-Vitro Diagnostics kits?

The medical devices market is growing at a fast pace along with the drug market despite all the challenges created by insufficient quality standards and other inconveniences. In India, medical devices are...

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DCGI-enlists

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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MoHFW Releases New Notification For The Registration And Labelling Requirements Of Medical Devices

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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