Govt makes it mandatory for all medical devices to get CDSCO
All imported, as well as locally manufactured medical devices sold in India, will soon be required to clear specific safety and quality standards. The move is aimed at preventing fiascos such as the one involving Johnson and Johnson hip implants.

A 2 April meeting of Drugs Technical Advisory Board (DTAB), India’s highest advisory body on drugs, decided to notify medical devices as drugs under the Drugs and Cosmetics Act (DCA), government officials aware of the development said.

Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI).

“The regulation will help ensure safe and tested medical devices reach the end user," the official cited above said on condition of anonymity. Currently, only 23 medical devices are regulated under the Act. The change will be implemented in a phased manner.

“Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time regarding safety, quality and performance of various medical devices, including diagnostic kits manufactured or imported in the country. Many of the medical devices like equipments analysers, instruments etc used in various healthcare facilities for diagnosis treatment, mitigation are currently out of scope of regulation under the Drugs and Cosmetics Act," the DTAB noted.

Read more through the official document for the DTAB meeting below.

Source: https://pxmd.co/DXcp6
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Apr 16, 2019Like