Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
Korea’s Ministry of Health and Welfare (MOHW) announced a new funding program on April 10, 2026. The initiative is designed to speed up the commercial rollout of AI-based medical devices. It focuses on the post-approval phase, where many products encounter challenges, as... Read More
Approximately 50% of global clinical trials are conducted in the Asia Pacific region today. The clinical trial landscape of Asia has been expanding beyond China in recent years. Although over 60% of the clinical trials in the region were initiated in China... Read More
Recent reforms to medical device registration in China are revamping how innovative products are approved for market entry. Collectively, these measures aim to reduce regulatory hurdles, enhance quality systems, encourage digital transformation, and promote international collaboration. This signals China’s ambition to move... Read More
Japan’s market for Software as a Medical Device (SaMD) is on track for remarkable growth, expanding from approximately 20 million USD in 2024 to more than 95 million USD in 2033. From 2025 through 2033, the SaMD market is forecasted to grow... Read More
Singapore’s Health Sciences Authority (HSA) has officially opened its new electronic Common Technical Document (eCTD) portal for test submissions. This represents an important move towards the process of digitalizing regulatory submissions for therapeutic products. The eCTD Specification Package version 1.0 will be... Read More
According to the recent Medical Facility Act in Thailand, telemedicine is now allowed and becoming more pervasive. Hospitals and clinics can diagnose, prescribe, and send out electronic prescriptions after a video call with a doctor is completed. Also, telepharmacy now permits a... Read More
A draft bill has been introduced in Korea to increase the scope of devices that can receive a designation as “innovative medical devices“. Innovative devices are those that would enhance the convenience and quality of diagnosis and treatment. At present, only devices with enhanced safety... Read More
Western drug makers are increasingly looking to Chinese biotechnology companies specializing in artificial intelligence to discover new medicines. A number of new multi-billion-dollar deals are a testament to China’s emerging status as a hub for cutting-edge medicines. In June, AstraZeneca paid more... Read More
As relationships with China falter and China wants to make everything in-country, more Western device companies are looking to India not only for sales, but for sourcing, R&D, local manufacturing, etc. The Indian government has promoted medical device manufacturing via its National... Read More