Medical Device Rules 2016 - Draft proposed by MOHFW
The government has prepared a draft notification viz. Medical Device Rules, 2016 for regulating manufacturing/ import/sale/clinical investigation and other matters concerning medical devices.

It has proposed that all unapproved medical devices marketed in the country would have to be licensed within six months of the draft rules.

Medical devices hereon will be classified based on the severity of the associated risk -

(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.

The draft rules can be read here -

http://cdsco.nic.in/writereaddata/Draft_Medical Devices Rules 2016.pdf
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