Medical Device Rules India, 2017: Classification of Medical Devices Regulations and Regulatory Approval for Registration
The classification of medical devices rules along with regulatory approval and registration by the CDSCO is under the control of Drug Controller General of India (DCGI). All medical devices in India follow a regulatory framework that is based on the drug regulations under the Drugs […]
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Forms and Purposes: The Medical Device Rules, 2016
The Indian Ministry of Health issued a set of new guidelines on 17 October, 2016 called “The Medical Device Rules, 2016” to define and regulate medical devices as a separate category. This move is to develop an in-depth regulatory framework […]
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India’s Latest Medical Devices Draft, 2016
The Union Health Ministry has released a draft for Medical Devices Rules under the existing Drugs and Cosmetics (D&C) Act and also a completely new rule to replace the 1940 Act. The Drugs and Cosmetics Act and Rules will likely […]
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Registration of Medical Devices in India
This article talks about the overall process of registration of medical devices in India. At the federal government level, medical device registration are processed by the Central Drug Standards Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. Manufacturers can […]
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