Good Manufacturing Practice in Indian context
Pharmaceutical Regulations in India
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 …
Continue reading “Conditions for manufacturing or loan licence”
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 …
Continue reading “Manufacturing Licence for Class C or Class D Medical Device”
Any person who intends to manufacture Class A or Class B medical device including the in vitro diagnostic medical device must apply to the state licensing authority through the online portal of Central Government in Form MD-3 (for licence) or MD-4 (loan licence) along with the required fees as specified in the second schedule and documents as specified in Part-II of the fourth schedule. The application should also accompanied by an undertaking that it complies with the Quality Management System, as specified in the Fifth Schedule