The recently issued draft National Medical Device Policy-2015 by the Department of Pharmaceuticals (DoP), mandates institutional frameworks such as common testing centres, Centers of Excellence, Made in India marking (BIS) for medical devices and a Skill Development Committee under National Medical Devices Authority. The government should set up common medical device testing facilities as per the policy to facilitate medical devices testing in manufacturing hubs.
READ ALSO: Medical Device Registration in India, Notified Medical Devices in India.
‘Centres of Excellence’ (CoE) for supporting product development and validation is also mandated by the draft policy. This would support design and prototyping, product development, validation and certification of the medical use of devices and adopt, implement and advocate policies on efficacy and safety testing. Made in India marking (BIS) specific to medical devices should also made in the lines of CE and FDA.
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