Regulatory Updates

Part 2: IFUs, the Chain of Responsibility and a Self-Check List Part 1 covered the six most frequent gaps in the label itself, and one thing that is most often misunderstood – symbols are not decoration. MDR 23.1(h) requires internationally recognized symbols to be used where appropriate, in line with applicable harmonized standards or common specifications (CS); but this cannot…

As of 22 August 2026, the Shanghai medical products administration’s public database lists 58 companies whose medical device business licenses explicitly include third-party storage and distribution services. Of these, 46 cover refrigerated and frozen ranges, while 12 are limited to ambient temperature. These 58 companies are not ordinary traders of Class III medical devices; they are license holders able to…

In the medical device industry, almost every extension of the EU MDR (Medical Device Regulation) transition period affects product lines that rely on EU certification to enter other markets. A recent notice from Australia’s TGA (Therapeutic Goods Administration) is a typical example of this knock-on effect – rather than designing its own transition timetable, it chose to follow the EU’s…

If your company is expanding into several overseas markets at once – say the EU, ASEAN and Latin America – you have probably experienced this: the same technical documentation often has to be reworked and resubmitted to meet each country’s requirements, with different review times and ever-growing communication costs. This “everyone for themselves” regulatory landscape is exactly what a major…

In most countries’ medical device classification systems, condoms are just one of many low-risk products. In Thailand, however, their status is special – they were the first product category in Thai medical device regulatory history to be covered by dedicated legislation, with a set of mandatory standards and testing requirements more detailed than those for ordinary Class 1/2 devices. For…

In recent years, more and more Chinese medical device companies have made Southeast Asia a key region for overseas expansion. Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam are all continuing to improve their medical device regulatory systems. For companies planning to enter Southeast Asia, a frequently asked question is: “We already have an ISO 13485 certificate – why should…

From 18 October 2026, the scope of mandatory halal certification in Indonesia will expand further to cover cosmetics, chemical products, household health products (PKRT), certain consumer goods and Class A risk medical devices, among others. This is not only a concern for Indonesian manufacturers; it is also quietly affecting companies that “seem” unrelated to halal certification – such as overseas…

Hyaluronic acid (sodium hyaluronate) fillers are generally placed in the highest risk class in the main Southeast Asian markets (Class 4 in Thailand; Class D in Vietnam, Indonesia, the Philippines, Singapore and Malaysia). What do regulators really care about when reviewing registrations for these products? And what should companies prepare in advance? This article covers both regulatory focus points and…

For Hong Kong and Macao medical devices that want to enter the Guangdong-Hong Kong-Macao Greater Bay Area market but have not yet been registered in the Mainland, the “Hong Kong and Macao Drug and Device Connect” (GBA Connect) scheme is an important compliant access channel. Based on the latest policy documents, EVERBIZ explains the legal basis, scope, process and key…

– 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…