Regulatory Updates

– From an ordinary baby product to a vital-signs monitoring device: one extra function can mean a completely different compliance pathway We recently came across a very representative project. The client previously made mainly toys and simple home products, and is now developing a baby bassinet/crib for the US market. The “crib” itself is not an unfamiliar product; what makes…

The Vietnamese government has issued Decree No. 37/2026/ND-CP (detailing the Law on Product and Goods Quality), fully replacing Decrees 43/2017/ND-CP and 111/2021/ND-CP and imposing stricter transparency and traceability requirements on medical device labeling. The new rules take effect on 1 July 2026, and medical device manufacturers, importers and distributors need to start reviewing and updating their existing packaging and labeling…

On 1 June 2026, Malaysia’s Medical Device (Designated Medical Device) Order 2026 (official reference P.U.(A) 10) came into force. Made under Section 26 of the Medical Device Act 2012 (Act 737), this subsidiary legislation brings a group of aesthetic/liposuction devices previously outside strict regulation – including medical lasers of specific wavelengths, HIFU (High-Intensity Focused Ultrasound) devices and liposuction systems –…

On 6 May 2026, the Philippine Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0594, formally launching the new “eSumbong” complaint and reporting system, integrated into the newly redesigned FDA website. The system is the FDA’s official centralized platform for receiving product- and establishment-related complaints and supporting market surveillance and enforcement, marking another important step in the Philippines’ compliance…

From 20 June 2026, new rules on medical device labeling and instructions issued by Thailand’s Ministry of Public Health (MOPH) came into force, fully replacing the labeling provisions in use since 2020. The new rules not only redefine the content requirements for labels and accompanying documents (Instructions for Use, IFU), but for the first time set specific provisions for electronic…

On 1 May 2026, Malaysia’s MDA (Medical Device Authority) and the Thai FDA (Thai Food and Drug Administration) jointly announced the full implementation of their Medical Device Regulatory Reliance Programme, after nearly six months of preparation and a three-month pilot. This is another regulatory cooperation mechanism of real practical significance in ASEAN, following the Singapore–Malaysia reliance arrangement. For medical device…

On 20 May 2026 the Singapore Health Sciences Authority (HSA) held an online industry briefing on medical devices, and published the briefing materials on 28 May. It covered updates on software medical devices, artificial intelligence (AI), in vitro diagnostics (IVD), dealer licences, the Special Access Route (SAR) and regulatory reliance with Malaysia. The summary below is based on HSA’s official…

As ASEAN’s trade hub and a preferred location for regional headquarters, Singapore is becoming the first overseas stop for more and more Chinese cosmetic brands. With its mature consumer market and access to ASEAN’s 600 million people, it attracts countless brands. Singapore’s Health Sciences Authority (HSA) operates a notification system for cosmetics – products must be notified before they are…

From 28 May 2026, some core modules of the EU EUDAMED system became mandatory. The one manufacturers care about most is UDI/Device registration – the UDI and device registration module. This means that for medical device companies planning to enter the EU market, UDI is not just a code on the label or a compliance chapter in the technical documentation,…

Some time ago, a client consulted us about a medical device with metal parts that was already on sale in several markets. The company had always focused on routine items such as biocompatibility, sterilization, packaging and performance testing. Until an overseas customer asked during a technical review: “Can this product be used in an MRI environment? Does the IFU include…

If you are considering selling medical devices in Southeast Asia, Malaysia is almost unavoidable as the first stop. The country has one of the most complete medical device regulatory systems in Southeast Asia, a mature market and clear policies, and regulatory cooperation between China and Malaysia has continued to deepen in recent years. This article takes you through it from…

They determine what kind of tank every liter of fuel you buy today comes out of. 1. It Started with “Leaking Steel Tanks” Twenty years ago, most gas stations in China had single-wall steel tanks buried underground. Such tanks are simple and cheap, but have an unavoidable drawback: steel plates buried in damp soil for a long time suffer electrochemical…