Legislative Reform Outlook
HK-unique · Proposed statutory framework
Current Status (May 2026)
Consultation on a Medical Devices Ordinance has been completed. As of May 2026, no ordinance has been enacted — MDACS remains operative.
What the Ordinance Would Change
| Aspect | Under Current MDACS | Under Proposed Ordinance |
|---|---|---|
| Legal basis | Administrative/voluntary | Statutory/mandatory |
| Offence for non-compliance | None specific | Criminal/civil offence |
| MDD enforcement powers | Limited | Formal search, seize, prosecute |
| Transition | — | Transition provisions expected for current MDACS listings |
What to Do Now
- Maintain current MDACS listings with up-to-date documentation
- Monitor the MDD website for legislative announcements
- When enacted, review transition provisions and plan any compliance gaps