On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview of the Medical Device Administrative Control System.
This document gives an overview of the MDACS (section 3). It then goes on to explain in detail the roles of a Local Responsible Person (LRP) within the system (section 4). Sections 5, 6, 7 and 8 give further information about the Listing System, including how to apply for the listing of devices, importers, local manufacturers and distributors.
The changes are:
- Update document format;
- Rename of Medical Device Control Office to Medical Device Division;
- Clauses 2 (Definitions and Abbreviations) has been updated. Reference is made to Guidance Notes GN-00 (Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System) for definitions
- Clause 4.4.3 (Keeping of Supply records) has been updated;
- Clause 4.4.7 (Management of product recalls and field safety notices) has been updated;
- Clause 5.5 (Submission of applications) has been updated;
- Clause 10 (References) has been updated;
- Clauses 3.3.2 and 8 have been added;
- Appendices 4 and 5 have been renumbered as Appendices 1 and 2; and
- Appendix 3, 4 and 5 have been removed.
For more information, please refer to:-
Website Tag:Hong Kong, Medical Devices