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
Singapore’s Health Sciences Authority (HSA) has spent the past year building a network of bilateral agreements that shorten approval timelines for medical devices and other health products. These agreements cover the UK, Malaysia, China, and Japan, and share a common mechanism: regulators... Read More
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
Thailand’s FDA has issued a new notification, effective July 16, 2026, that changes the documentation required to renew a drug registration certificate. Renewal is no longer a routine administrative step, as applicants must now demonstrate that their quality, efficacy, and safety documentation... Read More
Singapore’s Health Sciences Authority (HSA) and China’s National Medical Products Administration (NMPA) have renewed their regulatory cooperation agreement for health products, signing an updated Memorandum of Understanding (MOU) in Beijing on May 11, 2026. The revised agreement expands cooperation into newer areas,... Read More
On April 7, 2026, Beijing health authorities released a policy package with 32 measures to support innovative drugs and medical devices across the full lifecycle, from R&D to clinical use. Key actions include improving clinical trial infrastructure, accelerating regulatory review, and expanding... Read More
Singapore’s Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation in Tokyo on April 20, 2026. The agreement aims to bring the two regulators closer together in how they oversee drug products. At... Read More
Singapore’s Ministry of Health (MOH) has released new “Cybersecurity and Data Security Essentials” guidelines to support the rollout of the Health Information Act (HIA). The guidelines set out baseline requirements for healthcare providers handling patient data. They will be introduced in phases... Read More
In late January, Singapore’s Health Sciences Authority (HSA) published an updated guidance on defect reporting and recall procedures for therapeutic products in Singapore. The new guideline applies to therapeutic products, including biologics, as well as cell, tissue, and gene therapy products. It outlines what... Read More