On July 31, 2025, Taiwan’s Ministry of Health announced a phased plan to digitize drug package inserts, moving everything to a digital and paperless format. By December 31, 2025, all prescription and non-prescription drug inserts must be structured electronically and uploaded to... Read More
Over the past few years, Taiwan has enacted several significant reforms that have reshaped the regulatory framework for medical devices. These changes encompass a diverse range of topics, from regenerative medicine and digital health to product registration and classification, as well as... Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation... Read More
Japan is the third-largest medical device market in the world, so it warrants important attention by medtech companies planning their global commercial strategy for new products. But for foreign device firms the country is not an easy one in which to make... Read More
China’s pharmaceutical/biotech market offers enormous sourcing and manufacturing opportunities for foreign companies. However, one major challenge remains – product quality is a major concern for foreign firms seeking to procure pharmaceutical products from Chinese factories. Good quality systems that meet China’s National... Read More
On August 26, the MHLW released its FY2026 budget, which showed an increase of 550 billion yen from the previous year. The total 2026 budget is planned for about 35 trillion yen. There are many goals of the increased budget, including expediting... Read More
On July 21, 2025, Singapore’s Health Sciences Authority (HSA) published updated guidance for the risk classification of Software as a Medical Device (SaMD) and qualification of Clinical Decision Support Software (CDSS). The HSA wants to achieve three goals with the updated guidance:... Read More
China’s National Medical Products Administration (NMPA) issued a sweeping new policy to encourage the innovation and international competitiveness of high-end medical devices. Published in July 2025, the “Announcement on Optimizing Whole-Life-Cycle Regulation to Support Innovative Development of High-End Medical Devices” specifies ten... Read More
On August 5, 2025, India’s Central Drugs Standard Control Organisation (CDSCO) issued its first formal rule that stipulates how Subject Expert Committees (SECs) must review and approve new drugs, medical devices, and biologics. This policy change aims to resolve long-standing concerns related... Read More