Medical Device

RegistrationPost-marketClinicalMedical DeviceTestingInnovativeQualityChina AgentChinaLabeling
ClinicalClinical
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🍜 The China Clinical Trap

🍜 The China Clinical Trap

Common Mistakes of Manufacturers in Clinical Strategy

Elaine Tan
Medical DeviceMedical Device
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🍜 China Medtech: What You Missed in January

🍜 China Medtech: What You Missed in January

Catalogue updates, new guidance, standards watchlist

Elaine Tan
RegistrationRegistration
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🍜 China NMPA Revised Medical Device Classification Catalog

🍜 China NMPA Revised Medical Device Classification Catalog

What to do if your product is affected

Elaine Tan
Medical DeviceMedical Device
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🍜 China Regulatory 2025 Wrap Up

🍜 China Regulatory 2025 Wrap Up

What changed in 2025?

Elaine Tan
RegistrationRegistration
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🍜 Is Your EU Device Grouping Fit for China?

🍜 Is Your EU Device Grouping Fit for China?

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

Elaine Tan
ClinicalClinical
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🍜 Is Your EU MDR Clinical Evaluation Enough for China?

🍜 Is Your EU MDR Clinical Evaluation Enough for China?

Key differences between EU and China's CER

Elaine Tan
Medical DeviceMedical Device
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🍜 New China's GMP Update

🍜 New China's GMP Update

How China's GMP differs from ISO 13485?

Elaine Tan
RegistrationRegistration
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🍜 The Hidden Trap in China’s Type Testing

🍜 The Hidden Trap in China’s Type Testing

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

Elaine Tan
Medical DeviceMedical Device
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🍜 China's UDI Drafts in 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

🍜 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)

🍜 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

🍜 NMPA Approval with Real-World Data

What If Your Clinical Data Isn't Enough?

Elaine Tan