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Medical device regulations to be rewired to improve the quality and safety

The government is looking to put all medical devices under the admin- the administration of the Central Drugs Standard Control Organisation (CDSCO). This step is being taken to improve the quality and safety of the medical devices. Health Ministry has issued a draft notification asking to define all medical devices under Drugs and Cosmetics Act wef 1st December 2019. This draft would seek and record the information on import, manufacture and sale of all medical devices to be certified by CDSCO and manufacturers will have to get a license from the Drug Controller General of India (DCGI). Once these devices are classified under drugs, it would be the Central Drugs Standard Control Or- the organization’s (CDSCO) responsibility to regulate them. Industry sources claimed that there were plans afoot to create a separate statutory body for medical devices regulations that would run on the lines of the FSSAI, an autonomous body under the Health Ministry. As food is different from drugs, FSSAI was created to monitor it. Thus, NITI Aayog is also considering the option that a separate body could be created for medical devices. A draft Medical Devices Bill has been formulated and would be shared with all stakeholders within a quarter to take their viewpoint on same. Industry may be in favour of having a separate statutory body as devices were different from drugs. Now the government has to decide on overhauling of regulation for medical devices.

InnoHEALTH magazine digital team

Author InnoHEALTH magazine digital team

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