The Department of Health (DH) announced on June 26, 2025, that the Hong Kong Centre for Medical Products Regulation (CMPR) will be officially established by the end of 2026. This new regulatory body will oversee the comprehensive regulation of medical products, including medical devices.
The DH plans to implement a Primary Evaluation mechanism in phases starting from 2026, with full implementation targeted by 2030, marking a complete transformation of Hong Kong’s regulatory system.
Access the announcement and details here: Preparatory Office for the Hong Kong Centre for Medical Products Regulation
Key Highlights
CMPR Vision
To become a leading, internationally renowned medical products regulatory authority, driving excellence and innovation.
Primary Evaluation Mechanism
Independent assessments through CABs have been established in line with international standards.
Capacity Building
The DH is investing in professional training and enforcement capabilities to support the new regulatory framework.
Global Alignment
The CMPR will collaborate with international platforms such as GHWP and explore mutual recognition agreements to accelerate access to innovative devices.Greater Bay Area Collaboration
The CMPR will strengthen cooperation with Mainland authorities, including the National Medical Products Administration (NMPA) and the Greater Bay Area Center for Medical Device Evaluation and Inspection (GBACMDEI), to promote cross-border regulatory harmonisation.
Implementation Timeline
In 2026
A new bill for the statutory regulation of medical devices will be introduced to the Legislative Council.
By Q1 2026
The DH will develop a strategic plan for the CMPR.
By Q4 2026
- Launch the CMPR official website.
- Relocate existing regulatory services to CMPR’s temporary office.
- Host an official opening ceremony for the CMPR (a permanent headquarters is planned for the long term).
2030
With the new legislation in place, Hong Kong will fully implement the “Primary Evaluation” for all medical products, including medical devices, marking a complete transformation of the regulatory system.
References
- Preparatory Office for the Hong Kong Centre for Medical Products Regulation
- The Hong Kong Centre for Medical Products Regulation (CMPR) – Towards Primary Evaluation (Info Brochure)
Implications to Clients
If your medical device is not yet listed under the Medical Device Administrative Control System (MDACS), we recommend initiating the listing process as soon as possible to prepare for upcoming regulatory changes.
Effectivity
Phased implementation will begin in 2026.For assistance, contact us at info@nordpacificmed.com or click the button below.
