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
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
The Food and Drug Administration of the Philippines (Philippines FDA) officially declared that for Class A medical devices, the online application process to obtain the Certificate of Medical Device Notification (CMDN) is now the official route. Applicants must submit all CMDN applications through the... Read More
According to the Drug Information Association (DIA), the Chinese pharmaceutical market is still expanding rapidly, as the National Medical Products Administration (NMPA) approved 84 new drugs in 2024, 12% higher than in 2023 and way more than the 50 novel medicines approved... Read More