What Changed
- The Hong Kong SAR Government is drafting the Medical Devices Bill for submission in 2026 to transition medical device regulation from a voluntary listing system to a statutory regime.
- The Government will set up the Centre for Medical Products Regulation (CMPR) by the end of 2026 and estimates approximately 35,000 devices will ultimately require registration under the new law.
- Hong Kong SAR will host the Global Harmonization Working Party Annual Meeting in December 2026 to promote global regulatory alignment.
Local manufacturers, importers, wholesalers, healthcare institutions, and traders supplying medical devices in Hong Kong SAR are facing a transition from a voluntary listing framework to mandatory statutory regulation. In a written response to the Legislative Council on November 11, 2026, the Secretary for Health announced that the Hong Kong SAR Government is drafting the Medical Devices Bill to establish a statutory regulatory regime for medical devices in 2026.
Under the existing voluntary Medical Device Administrative Control System (MDACS) managed by the Department of Health (DH) since 2004, higher-risk general medical devices (Classes II to IV) and in vitro diagnostic medical devices (Classes B to D) are listed voluntarily. The total number of listed devices reached 11,052 by the end of October 2026, up from 4,782 at the end of 2023. However, because MDACS lacks statutory backing, the Government estimates that around 35,000 medical devices in the local market will ultimately require registration under the new legal framework. Products already listed under MDACS will transition to registered status without needing separate re-registration.
To support this transition, the Government is establishing the Centre for Medical Products Regulation (CMPR) by the end of 2026 to consolidate regulatory functions for medicines and medical devices. The DH also plans to expand its network of four recognized Conformity Assessment Bodies (CABs) and enhance its post-market surveillance system through improved data integration. Furthermore, the Government is addressing specialized manpower shortages in life and health technology, projected at 12,000 to 17,000 personnel across the innovation and technology sector by 2028.
Internationally, Hong Kong SAR will host the 30th anniversary Global Harmonization Working Party (GHWP) Annual Meeting in December 2026 to advance regulatory harmonization and support its ambition to become an international health and medical innovation hub. The Legislative Council Panel on Health Services will be briefed on the regulatory proposals on November 13, 2026.
Who May Be Affected
Medical device manufacturers, importers, wholesalers, healthcare institutions, and traders operating in or exporting medical devices to Hong Kong SAR.
Cross-Border Context
The regulatory reform aims to align Hong Kong SAR's medical product regulation with national development plans and international standards, fostering deeper collaboration with regulatory bodies in Mainland China and globally.
What to check next
- Briefing content delivered to the Legislative Council Panel on Health Services on November 13, 2026.
- Formal publication and gazetting of the Medical Devices Bill in 2026.
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.