Test License MD12/MD14 

Test License MD12/MD14 

Relevant Guideline: Medical Devices Rules, 2017.

Documents requirements: 

  1.  Cover letter
  2. Details of Devices
  3. List of equipment
  4. List of qualified personnel
  5. Justification of quantity proposed
  6. Test protocol
  7. QMS of Raw materials sourced

Time line: 7 days to 30 days

Fees:  500 INR each product

Validity of License: 3 years

(https://www.nsws.gov.in/)