In April 2021, Hong Kong Department of Health updated the guidances for listing of Class II/III/IV General Medical Devices and Class B, C and D In Vitro Diagnostic Medical Devices into the Medical Device Administrative Control System (MDACS).
GN-02: Guidance Notes for Listing Class II/III/IV General Medical Devices, 2021
This document is to provide guidance to applicants applying for inclusion of Class II/III/IV general medical devices into the List of Medical Devices under the Medical Device Administrative Control System (MDACS). It provides detailed information to the applicants for preparing the application submission.
Updates include:
- Update document format;
- Rename of Medical Device Control Office to Medical Device Division;
- Clause 5.3 (Submission of applications) has been updated;
- Clause 6 (Guide to Application Form MD-C2&3&4) has been updated;
- Appendix 1 Sample Application Form for Listing of Class II/III/IV Medical Devices has been updated to MD-C2&3&4 (2021 Edition); and
- Appendix 2 Sample Essential Principles Conformity Checklist has been updated to MD-CCL (2021 Edition)
GN-06: Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices, 2021
This document is to provide guidance to applicants applying for inclusion of the In Vitro Diagnostic Medical Device (IVDMD) into the List of Medical Devices under the Medical Device Administrative Control System (MDACS). It provides detailed information to the applicants for preparing the application submission.
Updates include:
- Update document style and layout;
- Rename of Medical Device Control Office to Medical Device Division; Clause 5.3 (Submission of applications) has been updated;
- Clause 6 (Guide to application form MD-IVD) has been updated;
- Appendix I Sample Application Form for Listing has been updated to MD-IVD (2021 Edition); and
- Appendix II Sample Essential Principles Conformity Checklist has been updated to Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices MDIVD- CCL (2021 Edition)
For more details please refer to: https://www.mdd.gov.hk/en/mdacs/issued-documents/guidance-notes/index.html/