Hong Kong to introduce mandatory medical device regulation by 2027
Hong Kong's health chief outlines legislative proposals to replace voluntary medical device controls with mandatory licensing and registration, aiming to enhance safety and support the city's ambition to become an international medical innovation hub.
Hong Kong's Secretary for Medical and Health, speaking at a Legislative Council health affairs committee meeting on 13 November 2026, outlined proposals to introduce statutory regulation of medical devices, replacing the current voluntary administrative scheme that has operated since 2004.
The government plans to table a Medical Devices Bill in 2027. The proposed framework would require local manufacturers, importers and wholesalers to obtain licences and maintain quality management systems. Medical devices would be classified by risk, with higher-risk products requiring pre-market registration while the lowest-risk devices would be exempt.
Post-market controls would oblige traders to monitor device safety, report adverse events and take corrective action. For specified high-risk devices, traceability mechanisms would be required to rapidly identify affected products and protect patient safety.
The proposals include exemptions for custom-made devices for individual patients and devices needed for public health emergencies, provided public health is not endangered. Clinical trial devices would not require registration but would need prior approval from the Department of Health.
An independent appeal mechanism would handle disputes over licensing and registration decisions. Traders and devices already listed under the existing voluntary scheme would transition directly to the new system.
The government said it would provide training, application templates and an electronic platform to help industry comply. The reform is part of Hong Kong's ambition, announced in the 2023 Policy Address, to become an international medical innovation hub, and follows the 2026 Policy Address pledge to establish a drug and medical device regulatory centre this year.
The Secretary said the legislation aims to ensure safety, foster innovation, align with international standards and build on the existing administrative scheme, applying a risk-based, lifecycle approach to regulation covering pre-market and post-market stages.
