Hong Kong's Path to Enhanced Medical Device and Drug Regulation
- Association Secretary
- 19 hours ago
- 2 min read
On February 3, 2026, the Department of Health held a significant seminar in collaboration with the Hong Kong Science and Technology Park, aimed at outlining the timeline and guidelines for the upcoming "First Level Approval" system in drug and medical device regulation. This event attracted representatives from local and mainland regulatory agencies, esteemed scholars, industry experts, and key figures in the medical technology sector.
Themed around "The Future of Medical Device Regulation," the seminar provided attendees with insights into the latest developments in Hong Kong's regulatory framework. The goal is to foster research, development, and clinical trials for medical products, ultimately allowing more patients timely access to advanced treatments.
Dr. Constance Chan, Director of Health, emphasized that 2026 marks a critical milestone for the innovation and regulation of drugs and medical devices in Hong Kong. The Government's policy address in 2025 announced the establishment of the "Hong Kong Drug and Medical Device Regulatory Centre" by 2026. This new center will implement a phased approach to the "First Level Approval" drug registration mechanism, enabling Hong Kong to evaluate the safety and efficacy of medical products based on clinical data autonomously. This initiative aims to position Hong Kong as an internationally recognized authority in medical device regulation.
Additionally, the government plans to submit legislative proposals for the regulation of medical devices this year. This will allow the industry to categorize their medical devices under the new regulatory framework promptly.
The Hong Kong SAR government continues to monitor advancements in innovative medical technologies and is committed to providing timely guidance to help the industry navigate regulatory requirements. Enhanced communication with stakeholders is a priority, fostering collaboration among industrial players, academic institutions, and research organizations. Since December of last year, the Department of Health has also been offering one-on-one consultation services for applicants wishing to submit new drug registration applications under the "1+" mechanism, free of charge.
The government encourages industry participants to take advantage of these services to achieve the goal of "early consultation, improved quality and efficiency, expedited registration, and access to quality medications in Hong Kong."
For more information or to get involved, please stay tuned for updates on upcoming initiatives and opportunities offered by the Greater Bay Area Healthcare Association. Together, we can pave the way for a healthier future in Hong Kong's healthcare landscape.
