The Manufacturing License for sale and distribution of Class A and Class B In- Vitro Diagnostic Kits are regulated by the State Licensing Authority. The manufacturing company shall submit their application to the State Drugs Control authority under whose Jurisdiction, the manufacturing Premises is located. The firm shall submit all relevant technical and administrative documents to the SLA requesting for License to manufacture IVDs.
The application for obtaining Manufacturing License for the intended In- Vitro Diagnostic Kits and reagents in Class A & B is filed in Form MD-3 and the application for obtaining loan licence is filed in Form MD-4 along with prescribed fees. Subsequently, the Manufacturing License for Class A& B IVD is obtained in Form MD- 5 and the Loan License is obtained in Form MD-6
Technical qualification of the staffs involved in the manufacturing process is to be submitted to the authority. The manufacturer of the notified diagnostic kits must conform to the requirements of Quality Management System as specified under the Fifth Schedule.
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