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 |
Centre for Medical Products Regulation
Hong Kong has announced plans to establish a Centre for Medical Products Regulation by the end of 2026, intended to strengthen the territory's regulatory capacity for medical products including devices, as part of the broader push toward statutory regulation.
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