Thailand is raising the bar for medical device software. A revised labeling regulation taking effect June 20, 2026, brings stricter documentation standards and, notably, the country’s first-ever unique device identification (UDI) requirement for software as a medical device (SaMD). The rule covers moderate... 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
China has revised its Good Clinical Practice (GCP) regulations for drug clinical trials, introducing new requirements focused on quality management, participant protection, investigator accountability, and the use of innovative technologies. One major change is the adoption of a Quality by Design (QbD)... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) revised its digital medical device labeling guidelines on June 10. The update follows industry difficulties after the Digital Medical Products Act took effect in January 2025. Key changes include a grace period permitting previous... Read More
China’s revised Implementing Provisions of the Drug Administration Law took effect on May 15, 2026. This marks the first major update to the regulations in more than two decades. Most notably, the use of overseas clinical research data in drug registration applications... Read More
Indonesia’s Food and Drug Authority (BPOM) issued Regulation No. 7 on Drug Promotion and Advertising on April 29, 2026. The new regulation outlines more detailed requirements for pharmaceutical promotion activities. Companies have until April 29, 2027, to make sure their existing advertisements... Read More
Japan is one of the world’s most important pharmaceutical markets, but foreign manufacturers cannot access it without first meeting Japan’s regulatory requirements. Besides submitting a Japanese drug registration dossier, clinical trial information, etc., — for drugs or quasi-drugs manufactured overseas, the applicant must... Read More
Japan continues to lag behind the United States in the registration of AI-based Software as a Medical Device (AI-based SaMD), particularly for products that continuously update after commercialization. Under Japan’s current regulatory framework, the Pharmaceuticals and Medical Devices Agency (PMDA) does not... Read More
China’s National Medical Products Administration (NMPA) has released updated Good Manufacturing Practice (GMP) rules. The new rules introduce a revised quality management system (QMS) framework and will take effect on November 1, 2026. The regulation applies to both domestic and foreign manufacturers... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a Q&A document clarifying how the revised conditional approval system under the amended Pharmaceuticals and Medical Devices (PMD) Act will be implemented as of May 1, 2026. The updated framework expands the... Read More