Conditions for manufacturing or loan licence

The manufacturing or testing activity should be performed only under the supervision of the competent technical staff and at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device should be maintained for 180 days after the expiry date. If applicable the medical device should be accompanied …

Manufacturing Licence for Class C or Class D Medical Device

Any person who intends to manufacture Class C or Class D medical device may apply to the central licensing authority through the online portal of Central Government in Form MD-7 (for licence) or MD-8 (loan licence) along with the required fees as specified in the second schedule and documents as specified in clause (ii) of …

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