Hong Kong medical device regulations

MDACS classification technical reference. English expression is TR-003:2024-1(E) (15 November 2024). Chinese expression TR-003:2025(C) (21 January 2025) is a later revision of the same document family, ingested as a separate language file, not a second corpus id.

Definitions and abbreviations for the Medical Device Administrative Control System (MDACS), English expression GN-00:2026-1(E), edition 6 dated 13 May 2026 per the printed revision history. Defines the terms used across the GN guidance family, including importer, distributor, local responsible person, and manufacturer roles, plus the abbreviated terms; edition 6 added Appendix 1. Ingested from the exact official PDF including the revision-history table; sections 1-5 and Appendix 1 carry stable anchors.

MDACS overview guidance notes, English expression GN-01:2026(E) (Ed 1.0), edition 11 dated 1 September 2026 per the printed revision history. Covers the voluntary listing system scope, local responsible persons, listing of devices/importers/manufacturers/distributors, delisting and appeal, and the Appendix 1 tracked-device list. Ingested from the exact official PDF including the revision-history table; the numbered chapters 1-11 plus Appendices 1-2 carry stable anchors.

Application guidance for listing Class II/III/IV general medical devices, English expression GN-02:2026(E) (Ed. 1.0), edition 10 dated 31 July 2026 per the printed revision history. Covers classification via TR-003, eligible applicants, application procedures with vetting timelines, appeal, and the clause-by-clause guide to application form MD101; sections 12-13 reproduce the sample MDS-01/MDS-02 declarations. Ingested from the exact official PDF including the revision-history table; sections 1-13 carry stable anchors.

Adverse event reporting guidance for Local Responsible Persons under the MDACS, English expression GN-03:2025(E), edition 6.0 dated 2 January 2025 per the printed revision history. Covers the three basic reporting criteria, reportable use errors, exemption rules with serious-public-health override, reporting timeframes (10/30 elapsed calendar days by severity, follow-up final report within 30 days), and the reporting form; Appendices 1-3 carry worked reportable/non-reportable examples, exemption explanations, and the adverse event report form. Ingested from the exact official PDF including the revision-history table; sections 1-9 and Appendices 1-3 carry stable anchors.

Conformity assessment framework and conformity assessment bodies under the MDACS, English expression GN-04:2026(E), edition 5 dated 1 September 2026 per the printed revision history. Covers the recognition of conformity assessment bodies, application and assessment procedures, suspension/withdrawal of recognition, appeal, and the Prevention of Bribery Ordinance clause. Ingested from the exact official PDF including the revision-history table; sections 1-8 carry stable anchors.

Application guidance for listing Class B/C/D in vitro diagnostic medical devices (IVDMD), English expression GN-06:2026(E) (Ed. 1.0), edition 11 dated 31 July 2026 per the printed revision history. Covers IVDMD classification via TR-006, eligible applicants, application procedures with vetting timelines, appeal, and the clause-by-clause guide to application form MD102; edition 11 deleted the former Appendix I sample form. Ingested from the exact official PDF including the revision-history table; sections 1-11 carry stable anchors.

Listing guidance for importers of medical devices under the MDACS, English expression GN-07:2026(E), edition 7 dated 1 September 2026 per the printed revision history. Covers the voluntary nature of importer listing, the MDIS application route with Form MD-IP+D, documented-procedure requirements, processing/approval of applications, administrative provisions including renewal and delisting, and appeal; Appendix I tabulates the required documented procedures and Appendix II reproduces sample documented procedures of an importer. Ingested from the exact official PDF including the revision-history table; sections 1-14 (13-14 being the appendices) carry stable anchors.

Listing guidance for local manufacturers of medical devices under the MDACS, English expression GN-08:2026(E), edition 6 dated 1 September 2026 per the printed revision history. Covers local-manufacturer status with business registration, an ISO 13485 (or equivalent) quality management system certified by a recognized or GACI-accredited body covering the whole Listed Scope of Manufacture, device-list reporting at 12-month intervals, advertising and record/inspection duties, MDIS application processing within 12 weeks, five-year listing validity with renewal 12 weeks to 1 year before expiry, delisting grounds, appeal within 14 working days, and the Prevention of Bribery Ordinance. Unlike GN-00..GN-10 this document prints unnumbered section headings: the 11 table-of-contents sections (Introduction through References) carry stable sec-1..sec-11 anchors, while the printed clause numbers cited in its revision history (e.g. clause 4.1.3) are not part of the PDF text layer, so sub-clauses are not separately anchored.

Listing guidance for distributors of medical devices under the MDACS, English expression GN-09:2026(E), edition 6 dated 1 September 2026 per the printed revision history. Covers application procedures through MDIS, requirements for listing of distributors including premises and documented procedures, processing/approval of applications, administrative provisions including renewal, and appeal; Appendix I carries the listing-requirements guidance and Appendix II a sample list of medical devices. Ingested from the exact official PDF including the revision-history table; sections 1-12 (11-12 being the appendices) carry stable anchors.

Change-control guidance for listed medical devices under the MDACS, English expression GN-10:2026(E), edition 3 dated 26 June 2026 per the printed revision history. Covers the classification of changes by flowchart, notification and approval routes with processing timelines, changes not requiring reporting to the MDD, withdrawal of listing, appeal, and the Prevention of Bribery Ordinance clause; Appendix I carries the change flowcharts and Appendix II the documents required for a change application. Ingested from the exact official PDF including the revision-history table; sections 1-13 (12-13 being the appendices) carry stable anchors.

Collection of guidance notes covering listing procedures, classification, and technical requirements for medical devices under MDACS.

Collection of official documents, circulars, and announcements issued under the Medical Device Administrative Control System.

MDACS is a voluntary listing system for medical devices. Devices must have valid marketing approval from a recognized reference regulatory authority (US FDA, EU, Japan, etc.).

The Medical Device Division (MDD) under the Department of Health regulates medical devices in Hong Kong through the Medical Device Administrative Control System (MDACS).

List of recognized reference regulatory authorities including US FDA, EU (CE Mark), Health Canada, TGA Australia, and PMDA Japan. Prior approval from one of these is required for MDACS listing.