Manufacture License for (Class A, B, C and D) Medical Devices
Relevant Guideline: Medical Devices Rules, 2017.
Documents requirements:
- Cover letter
- Location ownership/ agreement/ tenancy, details of constitution of the firm
- Test license
- Labelling
- Device Master File
- Site Master File
- Quality Management System Documents
- PSUR
Time line: 6 to 8 months
Fees: For Class A :1000 USD, Class B: 2000 USD, For Class C and D: 3000 USD