The scope of “Expedited Approval Scheme for Medical Device Listing Applications” will extend to include listing application of Class B/C/D In Vitro Diagnostic Medical Device
2024-08-12
Starting from 26 July 2024, the scope of “Expedited Approval Scheme for Medical Device Listing Applications” (“the Scheme”) will extend to include listing application of Class B/C/D In Vitro Diagnostic Medical Device. If you are interested in the Scheme, please submit the listing application via Medical Device InformationSystem (MDIS).
Please click here to view the issued documents:
- GN-06 (Guidance Notes forListing Class B, C and D In Vitro Diagnostic Medical Devices)
- Notes for the ExpeditedApproval Scheme
Source: https://www.mdd.gov.hk/en/
