Hong Kong’s Medical Device Division has updated its document checklist for medical device listing applications under the Medical Device Administrative Control System (MDACS). The MDACS framework requires all medical devices supplied in Hong Kong to demonstrate compliance with internationally adopted safety, quality,... Read More
Hong Kong’s Hospital Authority has launched a new office dedicated to fast-tracking the introduction of innovative drugs and medical devices into the public health system. The Office for the Introduction of Innovative Drugs and Medical Devices began operations on June 8, with... Read More
Hong Kong launched Phase 1 of its new “primary evaluation” regime for drug registration on March 31, 2026. The change supports the creation of the Hong Kong Center for Medical Products Regulation and moves the country closer to a fully independent drug... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
In a major shift from its history of reliance on overseas drug approvals, Hong Kong will start independently reviewing and approving drug products starting from next year. Currently, new drugs can be registered in Hong Kong after being approved by two or... Read More
Recently, there is a new regulation that allows the Thai FDA to hasten the review of device registration dossiers. It has agreed to let device companies reference registration dossiers for new registrations of the same product with different brand names. In short, the Thai FDA is... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
As mentioned recently in our newsletter, Hong Kong’s Health Authority is being bulked up to take more responsibility in approving healthcare products. This past summer, the Department of Health set up the Hong Kong Centre for Medical Products Regulation. Whereas in the... Read More
The Department of Health (DH) is set to enhance its medical device procurement strategy, building on the first phase implemented on June 21, 2023. The second phase of this strategy will be introduced in two stages to ensure better quality and safety... Read More
On June 5, Hong Kong’s Department of Health (DH) announced the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR). This initiative seeks to enhance the regulatory and approval processes for pharmaceuticals and medical devices in... Read More