In recent times, India has emerged as the world's leading manufacturer of medical products. The medical device industry is a multi-product sector, manufacturing a wide variety of products. India's medical sector is rising as a key market for medical devices and diagnostics. These medical devices have not been controlled at an early stage, but according to the amended Drugs & Cosmetics Act, 1940, in 2006, the Central Drugs Quality Control Organization (CDSCO) clarified that medical products must be controlled under the Medical Device Regulations, 2017. CDSCO will also control the import, manufacture, distribution and selling of medical devices.
The goal of CDSCO is to safeguard and improve public health by ensuring the safety, effectiveness and efficiency of medicines, cosmetics and medical devices. CDSCO also regulates the standard of imported medical devices in port offices by the Central Licensing Authority and the State Licensing Authority. Although there is a limited list of regulated products, CDSCO periodically adds new items to the lists as well as changes to the regulatory framework in India. This article provides a summary of India's current regulatory system.
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