Medical Equipment Product Registration

Below is the list of documents required to proceed the Class A product registration with Medical Device Authority (MDA) General Documents:

1. Letter of Authorization as Authorized Representative, importer and Distributor from Manufacturer (follow template)

2. Product List to be register with MDA (Attachment 1, Letter of Authorization)

4. ISO 13485 certificate from Manufacturer

5. Pre-Market Approval (please provide either one) of below: -

     a. CE certificate
     b. USFDA - required document is 510(K) Clearance Letter and Pre-market Approval (PMA) Approval Letter
     c. TGA Australia - required document Health Canada Medical Device License
     d. Canada Health - required document Health Canada License
     e. Japan MHLW - required document Ministry of Health, Labour and Welfare (MHLW) License

6. Product Catalogue.

7. Pre-clinical studies -safety report especially for active device 

8. Labelling on packaging (pls refer to product label)

9. Instruction of use

10. DOC-Declaration of Conformity

11. PMS-Pre Market Survellance