Introduction to the GDPR (General Data Protection Regulation) for EU Medical Devices
Regulation (EU) 2016/679 (the General Data Protection Regulation, GDPR, on the protection of natural persons with regard to the processing
Regulatory News
Global medical device regulatory updates and registration guides
How Can Manufacturers Hedge Risk Through Insurance Under the MDR?
The EU MDR (EU 2017/745) is not only a technical regulation but also a “liability regulation”. For medical device manufacturers,
What Class Are Disposable Urine Bags and Vomit Bags Under the MDR? Why Are They So Often Misclassified?
In our medical device registration consulting work we have found a very common misconception: simple collection products such as disposable
Understanding the FDA’s Stricter EMC Requirements for Common Electromagnetic Emitters
Recently, many companies undergoing FDA 510(k) EMC review have received similar requests for additional information: Please provide immunity data related
How to Avoid Conflict Minerals Risk: A Complete Guide to the CMRT | EVERBIZ Compliance Class
In recent years, whether you make electronics, medical devices, machinery, metal parts or consumer goods, your downstream customers (especially in
Why Is Amazon Full of “Home Nebulizers”? The Truth Hidden Between FDA Regulations and Amazon Policy
Among cross-border sellers, one product category has been booming over the past two years – the nebulizer. Type “nebulizer” into
The CE-MID Directive Explained: Don’t Mistake Laboratory Instruments for Legal Metrology Equipment
When exporting to the EU market, many instrument manufacturers ask: “My instrument/meter needs CE marking for export to the EU
[EVERBIZ EU Regulations Column] Which Products Fall Under the EU GPSR? Why Do Some Consumer Products Need CE Marking and Others Don’t?
1. Why do some products need CE marking and others don’t? Many clients ask us: “They are all consumer products
Key Changes in China’s New Medical Device GMP: Effective 2026 – A Must-See Comparison Table
On 4 November 2025 the National Medical Products Administration (NMPA) issued the new Good Manufacturing Practice for Medical Devices (the
Japan PSE Certification Explained: Application Steps, Testing Requirements and Marking Rules
Step-by-step overview of the PSE process for Specified (diamond PSE) and Non-Specified (round PSE) electrical products in Japan, including technical files and marking rules.