Documents required
1. An Undertaking by the applicant detailing the required facilities such as equipment, instruments & personnel for the manufacturing of medical devices
2. List of equipment, and instruments used for manufacturing
3. List of qualified personnel employed by the applicant
4. Justification of submitted quantity to be manufactured by the applicant
5. Test protocols for testing finished medical devices/equipment
6. Quality Management Certificates from the war material supplier
7. Manufacturing license issued by the State Pollution Control Board
8. Site Layout / Site Plan
9. Certification of a site with a detailed raw component
10. DPR/Process Flow Chart