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🍜 Is Your EU MDR Clinical Evaluation Enough for China?
Nov 27, 2025

🍜 Is Your EU MDR Clinical Evaluation Enough for China?

Key differences between EU and China's CER

Elaine Tan
Medical DeviceMedical Device
+2+2
🍜 New China's GMP Update
Nov 13, 2025

🍜 New China's GMP Update

How China's GMP differs from ISO 13485?

Elaine Tan
RegistrationRegistration
+2+2
🍜 The Hidden Trap in China’s Type Testing
Oct 30, 2025

🍜 The Hidden Trap in China’s Type Testing

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

Elaine Tan
Medical DeviceMedical Device
+2+2
🍜 China's UDI Drafts in 2025
Oct 16, 2025

🍜 China's UDI Drafts in 2025

New Deadlines, Exemptions, and a Surprise Link to NHSA

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 Foreign Firms: Don’t Miss China’s Self-Testing Shift
Oct 01, 2025

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

China’s New Self-testing Guidance Explained

Elaine Tan
ClinicalClinical
+2+2
🍜 Success Stories of Real-World Data (Part 2)
Sep 18, 2025

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

How Hainan became China’s medtech pilot zone

Elaine Tan
ClinicalClinical
+1+1
🍜 NMPA Approval with Real-World Data
Sep 05, 2025

🍜 NMPA Approval with Real-World Data

What If Your Clinical Data Isn't Enough?

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China's Online E-Commerce
Aug 21, 2025

🍜 China's Online E-Commerce

When online specs meet medical device compliance rules

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China's New Risk Rules
Aug 07, 2025

🍜 China's New Risk Rules

NMPA Draft Could Up-Class Your Device

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 Future of Medical Device Industry in China (Part 2)
Jul 24, 2025

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

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 Future of China's Medical Device Industry (Part 1)
Jul 17, 2025

🍜 Future of China's Medical Device Industry (Part 1)

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 EU-China Tension Over Medical Device Procurement
Jul 10, 2025

🍜 EU-China Tension Over Medical Device Procurement

What it means for global supply chains

Elaine Tan
Unlock China’s market access and regulatory compliance for medical devices.

Medtech Chopsticks

Unlock China’s market access and regulatory compliance for medical devices.

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