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Website. cdsco .gov .in and www .cdscoonline .gov .in. 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.
The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Design controls. Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices ).
Meril Life Sciences is an Indian multinational medical device company, with headquarters in Vapi, Gujarat, India. It was founded in 2006 and is a part of the Bilakhia Group. The company is engaged in the manufacturing of vascular intervention devices, orthopedic implants, endosurgery, ENT products and in-vitro diagnostics. Meril Life Sciences ...
A substance based medical device is a medical device composed of substances or combinations of substances. They are typically differentiated from medication (drugs) in that they do not have pharmacological, immunological or metabolic mode of action but achieve their therapeutic effect through primarily physical means.
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