Over the course of 2026, Korea’s Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare (MOHW) introduced a series of measures that affect nearly every stage of a medical device’s lifecycle in Korea. Most of these measures serve... Read More
Medical device registration in Malaysia is mandatory for any medical device imported, exported, or placed on the Malaysian market. The Medical Device Authority (MDA), an agency under the Ministry of Health, administers the registration system. Foreign manufacturers must work through a licensed... Read More
Korea runs a single-payer National Health Insurance (NHI) system that covers about 97% of the population, or roughly 52 million people. Ranked 10th globally and 3rd in Asia, the Korean medical device market was worth an estimated USD 7.5 billion in 2025.... Read More
Japan’s Cabinet Office is requesting 22 billion yen (about 143 million USD) in its FY2027 budget to help pay for clinical trials, as part of a wider push to invest in drug discovery and advanced medicine. All of the money will go... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has revised its regulation on post-market surveillance of medical devices by clarifying the criteria and required documentation for exempting rare disease devices with overseas use experience from Korea’s surveillance requirement. Post-market surveillance confirms the... Read More
China has quickly become a major force in drug innovation. A US congressional commission said last year that the country’s biopharmaceutical sector had gone from a minor player to a dominant one in just the last few years. Beijing has named biotech... Read More
India has amended its Medical Devices Rules 2017 to ease regulatory requirements for their medical device sector. Rule 63 now recognizes European Union approvals as sufficient grounds to waive clinical trial requirements in India, adding the EU to a list that already... Read More
China’s National Medical Products Administration (NMPA) has issued new inspection guidelines for medical device manufacturers (Notice No. 14 of 2026, dated September 17). These guidelines come ahead of the revised Good Manufacturing Practice (GMP) for medical devices, which takes effect on November... Read More
ASEAN member states have agreed in principle to roll out a Single Submission Model for pre-market medical device approvals in phases. Malaysia will serve as the coordinating hub for technical document submissions. The consensus came out of the first ASEAN Medical Device... Read More
Singapore’s Health Sciences Authority (HSA) published the finalized Best Practices Guide for Medical Device Cybersecurity in August 2026. This Guide outlines cybersecurity recommendations for medical device manufacturers and healthcare providers. The Guide is aimed at keeping devices secure across their entire Total Product Life... Read More