Medical Device Registration
From Regulatory - CDSCO
Medical Device Registration in India is overseen by the CDSCO, under the Directorate General of Health Services in the Ministry of Health & Family Welfare. To get a Medical Device Registration without any hassle, contact Corpbiz.
An Overview of CDSCO Medical Device Registration in India
Currently, India is one of the top global medical device markets with a massive contribution from device imports. Earlier, the manufacturers in India could sell medical devices without any jurisdiction. Since 2006, medical devices entering India should be in compliance with the Indian Medical Device Regulations set by the CDSCO. Today, there is a proper system for Medical Device Registration in India for specific types of medical devices managed under the Medical Device Rules.
The CDSCO (Central Drug Standard Control Organisation) regulates medical devices in India and IVD (In-Vitro Diagnostics) marketed in India. The CDSCO is headed by the DCGI or Drug Controller General Of India and the approval authority is shared between SLA (State Licensing Authority) and CLA (Center Licensing Authority). In India, the manufacturing, import, sale & distribution of medical devices are regulated under the Drugs And Cosmetics Act, 1940 And Rules 1945. So, it is necessary to obtain CDSCO Medical Device Registration in India.
Which Regulatory Bodies are Responsible for CDSCO Medical Device Registration in India?Following are the main regulatory bodies that are responsible for CDSCO Medical Device Registration in India:
- The Drug Controller General of India (DCGI) is responsible for the manufacturing approval of certain drugs such as blood products, vaccines, large volume parenteral, r-DNA derived), specified medical devices, and new drugs;
- The CDSCO (Central Drug Standards Control Organisation) is the main regulatory body in India for pharmaceuticals & medical devices;
- In India, the import, sale, manufacturing, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Acts and Rules.
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