EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
The Two “Foreign Standards” Behind the Tank Replacement Wave at China’s 100,000 Gas Stations: UL 1316 and UL 1746
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 Must-Read for Non-EU Exporters: Getting Instruments and Measuring Equipment into the EU Market
As global trade deepens, more and more Chinese companies want to export instruments and measuring equipment to the EU. Technical compliance (CE marking) is key, but beyond regulations, exporting to the EU also involves a series of practical requirements and market access conditions. This article sets out the whole process to help your products enter…
South Korea Medical Device Export Registration in Depth: From Regulations to Practice
South Korea is one of the world’s major medical device markets, with a mature and continuously updated regulatory system. Since 2025, the Digital Medical Products Act has been in force, creating a dedicated pathway for innovative products such as AI and digital therapeutics. South Korea also now allows joint KGMP (quality management system requirements) and…
Korea Medical Device FAQ 2025 (2025 자주하는 질문집 의료기기) – Download
This resource is the 2025 edition of the Korean medical device regulatory FAQ (original Korean version), compiling the questions companies most often encounter in medical device licensing, filing and post-market management in Korea, together with official answers. About this document Medical devices in Korea are regulated by the Ministry of Food and Drug Safety (MFDS)…
Japan Medical Device Registration in Depth: Regulatory Framework, Classification Routes and Practical Experience with the Latest Amendments
Japan is the world’s second-largest medical device market and an important target for Chinese medical device companies going global. Its regulatory system is known for being rigorous and detailed. Based on official interpretations from Japan’s Ministry of Health, Labour and Welfare (MHLW) and industry practice guides, this article gives a one-stop overview of Japanese medical…
Market Access Guide for Exporting Veterinary X-Ray Machines to the US
1. The Five Compliance Requirements at a Glance Although veterinary X-ray machines are not subject to FDA 510(k) requirements for human medical devices, as ionizing radiation-emitting equipment they still have to meet the compliance requirements of several US federal agencies and state governments. 2. FDA CDRH Radiation Product Reports (the Most Overlooked Mandatory Item) ▎Why…
Which Products Are Subject to the EU Data Act?
Recently, more and more companies exporting to the EU have encountered a new issue: European buyers require products to comply with the EU Data Act. Many companies’ first reaction is: we only make treadmills, watches, appliances and equipment – why would a “data act” concern us? The reason is simple: many products today are no…
2026 Guide to Saudi SFDA Medical Device Registration and Doing Business: New Regulations and Market Access Explained
As Saudi Arabia’s Vision 2030 strategy advances, the largest medical device market in the Middle East is undergoing a deep regulatory upgrade. The Saudi Food and Drug Authority (SFDA) issued a series of new rules in early 2026, from electronic submission to risk classification. This article systematically sets out the latest requirements and practical points…
An Underestimated Market Opportunity: The Industry Being “Medicalized” Behind the Shanghai Adult Expo
The 2026 Shanghai Adult Expo was busier than ever. But what really deserves attention is not just its size, but a change in trend: adult products are rapidly becoming “medicalized”. From material safety and biocompatibility to ergonomic design, app connectivity, data recording and even AI algorithms, the industry is steadily moving closer to medical devices.…
FDA: The Complete Compliance Path for Medical Device Biocompatibility Submissions
In FDA submissions for medical devices, biocompatibility assessment is an unavoidable core element. The FDA guidance Use of International Standard ISO 10993-1 (the “FDA general guidance”), the FDA guidance Chemical Analysis for Biocompatibility Assessment of Medical Devices (the “FDA chemistry guidance”) and ISO 10993-1 are the three “programmatic documents” for biocompatibility compliance. Many companies confuse…
FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices – Download
This resource is the guidance document “Chemical Analysis for Biocompatibility Assessment of Medical Devices” published by the US FDA (Food and Drug Administration), which guides companies on using chemical characterisation to support biocompatibility evaluation. About this document The guidance sets out the FDA’s expectations for extractables and leachables (E&L) studies, including selection of extraction conditions,…
FDA Guidance: Use of International Standard ISO 10993-1 – Download
This resource is the US FDA (Food and Drug Administration) guidance on applying ISO 10993-1 to the biological evaluation of medical devices within a risk management process. It is one of the most important references for the biocompatibility section of FDA submissions. About this document The guidance explains the extent to which the FDA recognises…