🍜 China Regulatory 2025 Wrap Up

What changed in 2025?

🍜 Is Your EU Device Grouping Fit for China?

Key differences between EU Basic UDI-DI and China Registration Unit

🍜 Is Your EU MDR Clinical Evaluation Enough for China?

Key differences between EU and China's CER

🍜 New China's GMP Update

How China's GMP differs from ISO 13485?

🍜 The Hidden Trap in China’s Type Testing

Why your ISO/IEC compliance might still fail NMPA tests.

🍜 China's UDI Drafts in 2025

New Deadlines, Exemptions, and a Surprise Link to NHSA

🍜 Foreign Firms: Don’t Miss China’s Self-Testing Shift

China’s New Self-testing Guidance Explained

🍜 Success Stories of Real-World Data (Part 2)

How Hainan became China’s medtech pilot zone

🍜 NMPA Approval with Real-World Data

What If Your Clinical Data Isn't Enough?

🍜 China's Online E-Commerce

When online specs meet medical device compliance rules

🍜 China's New Risk Rules

NMPA Draft Could Up-Class Your Device

🍜 Future of Medical Device Industry in China (Part 2)