Singapore has quickly become a regional leader in digital health innovation thanks to its strong regulatory frameworks for emerging technologies, including mobile health applications, connected wearables, and AI-enabled devices. As healthcare delivery increasingly makes the transition to digital platforms over the years, the Singaporean Health Sciences... Read More
Ten to twenty years ago, Japan medical device reimbursement normally equaled the reimbursement in the US, or in a few cases, even higher. During this time, some device companies had 10% of their sales in Japan, with more than 10% of their... Read More
In mid-September, China’s National Medical Products Administration (NMPA) launched a 30-day review and approval pathway for investigational new drug (IND) applications to speed up clinical trial initiation for innovative pharmaceuticals. This pathway supplements the existing 60-day default approval pathway established in 2019.... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has made a major overhaul to its disclosure policies regarding Good Manufacturing Practice (GMP) inspection outcomes. The MFDS will now disclose results in full, instead of in the past, just issuing heavily redacted... Read More
To register medical devices in China, type testing is required. Whereas in the past, this testing needed to be done in China, China has now allowed for testing overseas. Given the long time it may take for type testing in China (anywhere... Read More
Drug reimbursement is a key issue in Japan, especially as the country wants to promote innovative therapies and reduce the drug lag/loss there. Over the last few months, the MHLW, Central Social Insurance Medical Council (Chuikyo), the Japan Pharmaceutical Association, and other... Read More
India is moving toward an extensive revision of its legal drug-quality measures, which will be aligned with the various drug standards of the US, EU, and Japan. The Indian Pharmacopoeia Commission (IPC) will include new drug quality measures for 123 products and... Read More
Singapore’s Health Sciences Authority (HSA) has strengthened international regulatory collaboration through two Memoranda of Understanding (MOUs) signed during the 16th International Conference on Medical Regulation 2025. On September 4, the HSA signed an MOU with Australia’s Therapeutic Goods Administration (TGA) to facilitate... Read More
Device registration in Malaysia is done by a Local Authorized Representative (LAR) for foreign device manufacturing companies without a physical presence in Malaysia. The normal device registration process includes going through a detailed conformity assessment before making a registration application submission. In... Read More
Indonesia requires most imported foreign products to meet its strict Halal requirements. The deadline for meeting Halal requirements has recently been extended. Different product categories have new certification deadlines. For our readers, these deadline extensions are important – 1. October 17, 2026,... Read More