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