India will soon make it mandatory for all locally manufactured and imported medical devices to pass through specific quality and safety standards before they are sold in India, reports Mint.
Commenting on the need for this new regulation, India’s apex advisory body on drugs Drugs Technical Advisory Board (DTAB) said, “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 equipment analysers, instruments etc., used in various healthcare facilities for diagnosis treatment, mitigation are currently out of the scope of regulation under the Drugs and Cosmetics Act,” added DTAB.
As per a 2 April meeting, medical devices sold in India will now be classified as drugs for the purposes of the Drugs and Cosmetics Act, 1949 by Drugs Technical Advisory Board (DTAB).
“The (new) regulation will help ensure safe and tested medical devices reach the end user," said a government official. The change will be implemented in phases.
CDSCO Approval Must
Once this notification comes into effect, the manufacture and sale of all medical devices would have to be certified by the Central Drugs Standard Control Organisation (CDSCO) for safety. Those firms that manufacture such devices in India will also need to get licences from the Drug Controller General of India (DCGI).