Hong Kong Department of Health: This year will be a milestone in the regulation of pharmaceutical and medical device innovation in Hong Kong, China, achieving the goal of "Good drugs are used in Hong Kong, and good devices are used in Hong Kong".

On February 3, Dr. Lin Wenjian, Director of the Hong Kong Department of Health, stated at a seminar on drug and medical device (medtech) regulation that 2026 will be a milestone for the development of innovative regulation of medical devices in China and Hong Kong. The "Chief Executive's Policy Address for 2025" announced that the Hong Kong government will establish the "Hong Kong Centre for Drug and Medical Device Regulation" by 2026, and will begin implementing a phased "first level approval" system for new drug registration within the same year. This will allow Hong Kong to independently assess and approve the safety and efficacy of medical devices based on clinical data, becoming an internationally recognized authority in medical device regulation. The establishment of the "first level approval" system will accelerate the development of innovative medical devices, realizing the goal of "Good Medicine in Hong Kong, Good Devices in Hong Kong". In the phased implementation of the "first level approval" system, the Hong Kong Department of Health will initially cover registration applications for products with registered chemical elements being used in extended applications (such as new indications, new dosages, new methods and doses, new dosage forms, etc.), gradually establishing a comprehensive approval system to inject strong momentum into the development and market expansion of the healthcare industry in the Hong Kong Special Administrative Region, as well as the nation and other regions. Dr. Lin Wenjian mentioned that the Hong Kong government will also propose legislation this year to regulate medical devices, encouraging the industry to promptly list their medical devices in the administrative management system for medical devices, and prepare for the transition to future legal frameworks as soon as possible. He added that the Hong Kong Department of Health has been closely monitoring the technological development of Innovative Medical Management devices and issuing timely guidance, such as developing technical reference documents for listing artificial intelligence medical devices, assisting the industry in understanding the relevant requirements. This year, with strong support from the National Medical Products Administration, the Hong Kong Department of Health will host the annual meeting of the Global Coordination Meeting on Medical Device Regulations, bringing together representatives from global medical device regulatory agencies and industry leaders in Hong Kong. This aims to establish global medical device regulatory systems through the "Hong Kong Centre for Drug and Medical Device Regulation", potentially becoming a leader and laying the initial foundation. Furthermore, the Hong Kong Department of Health has been providing "one-on-one" consultation services since December last year for applicants intending to submit new drug registration applications under the "1+" system. Dr. Lin Wenjian encouraged the industry to apply actively, working towards the goal of "pre-consultation, quality improvement, accelerated registration, and good use of drugs in Hong Kong", and consolidating Hong Kong's position as an international hub for medical innovation. This service aims to further optimize the new drug registration approval process, and there will be no charges for the related services at this stage.