Hong Kong Centre for Medical Products Regulation to be established by the end of 2026

On 9 July 2025, the Hong Kong Department of Health announced that the Centre for Medical Products Regulation (CMPR) will be established by the end of 2026, with a legislative proposal expected to be submitted to the Legislative Council within the next year. The Preparatory Office for the Hong Kong Centre for Medical Products Regulation was established under the Department of Health in June 2024 to prepare for the CMPR and examine options for strengthening the regulatory and approval regimes for drugs and medical devices.

This development represents the Hong Kong government’s ongoing commitment to align the regulation of medical devices with international standards and safeguard public health.

Expected key regulatory changes

• Expanded scope of registration: Under the prevailing Medical Device Administrative Control System (MDACS), medical devices are listed (and thereby regulated) on a voluntary basis. In other words, medical devices not listed in the MDACS, depending on their characteristics and features, are only regulated by legislation such as the Pharmacy and Poisons Ordinance (Cap. 138), Consumer Goods Safety Ordinance (Cap. 456) and Trade Descriptions Ordinance (Cap. 362) (TDO), which are not specifically designed for medical devices. The Hong Kong government announced that once new legislation is passed, all medical devices supplied in Hong Kong, unless otherwise exempted, must be registered.
   
• Enhanced pre-market control: In the absence of a mandatory system, no comprehensive pre-market mechanism currently exists to assess the safety, performance and quality of all medical devices. For example, parallel-imported medical devices may be promoted and sold online without any medical device labelling raising product safety and traceability concerns. It is expected that upon legislation, all regulated medical devices  must meet the internationally recognised Essential Principles of Safety and Performance of Medical Devices, thereby providing stronger safeguards for public health.
   
• Strengthened post-market surveillance mechanisms:  At present, the Medical Device Adverse Event Reporting System is designed for products listed under the MDACS only. For adverse events involving unlisted medical devices, consumers may resort to filing complaints with the Consumer Council or reporting  suspected contravention of the TDO to the Customs and Excise Department. Once the legislation is in place, there will be a dedicated reporting system facilitating early detection of safety alerts, offering enhanced protection for users.
   
• Improved adequacy of product information: With the imposition of more stringent requirements on the labelling, packaging and marketing of medical devices, members of the public and industry participants will have more comprehensive product information at their disposal, enabling them to make informed decisions regarding the safe use of medical devices.

Considerations for business

To navigate these regulatory developments effectively, all entities within the medical device supply chain, including manufacturers, distributors, and importers, should proactively take the following measures:

• Conduct a comprehensive compliance audit: Undertake a thorough review of the current practices, policies, and procedures. Identifying gaps at an early stage will allow sufficient time to implement necessary changes before mandatory deadlines.
   
• Review contracts and agreements: Ensure that your commercial contracts clearly delineate responsibilities and liabilities associated with compliance under the updated regulations. This includes provisions relating to indemnification, warranties, and obligations to promptly report and address adverse events.
   
• Update internal systems and procedures: Review and revise relevant quality management frameworks, product recall processes, and data reporting systems to ensure their alignment with the proposed requirements.

For more information on the regulations governing medical devices in Hong Kong, contact your CMS client partner or these CMS experts: Jonathan Chu; Mengyi Chen; Tiffany Sien