• Single regulatory framework likely for all medical devices

    • October 10, 2019
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    All imported and locally-made medical devices will have to meet certain standards of quality and efficacy to enter the Indian market. The government has begun framing the rules and a draft notification to this effect is likely to be put out soon, people aware of the matter told ET.

    Currently, only 23 categories of medical devices are regulated in India under the Drugs and Cosmetics (D&C) Act. The change to bring all medical devices under regulation will be implemented in a

    phased manner.

    According to the persons cited earlier, certification of devices by the Central Drugs Standard Control Organisation (CDSCO), regulatory authority in this case, will be on voluntary basis up to 18 months from date of notification, and thereafter it will be made mandatory.

    Once the rules get notified, all import, manufacture and sale of medical devices will need to be certified by the CDSCO. “The new rules will be incorporated in the existing Act,” said a senior

    official, requesting not to be named.

    “We cannot be lax about standardisation and quality of medical devices. There is a consensus now among all departments and we will soon put up a draft notification. All medical devices will have to be registered with the regulatory authority before they enter the market,” the official said.

    The decision is part of a move to increase safety of end users of such devices. Last year, problems due to hip implants manufactured by a subsidiary of Johnson & Johnson (J&J) required some patients to undergo revision surgery.
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