MD26/MD27 (IVD/MD) Import License

Manufacture License for (Class A, B, C and D) Medical Devices

Relevant Guideline: Medical Devices Rules, 2017.

Documents requirements: 

  1.  Cover letter
  2. Location ownership/ agreement/ tenancy, details of constitution of the firm
  3. Test license
  4. Labelling
  5. Device Master File
  6. Site Master File
  7. Quality Management System Documents
  8. PSUR

Time line: 6 to 8 months

Fees:  For Class A :1000 USD, Class B: 2000 USD, For Class C and D: 3000 USD