Medical Device

Registration Post-market Clinical Medical Device Testing Innovative Quality China Agent China Labeling

Medical DeviceMedical Device

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Feb 25, 2026

🍜 China Monthly Regulatory Signals

February 2026: Direction, guidance, standards watchlist

Elaine Tan

ClinicalClinical

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Feb 11, 2026

🍜 The China Clinical Trap

Common Mistakes of Manufacturers in Clinical Strategy

Elaine Tan

Medical DeviceMedical Device

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Jan 29, 2026

🍜 China Medtech: What You Missed in January

Catalogue updates, new guidance, standards watchlist

Elaine Tan

RegistrationRegistration

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Jan 15, 2026

🍜 China NMPA Revised Medical Device Classification Catalog

What to do if your product is affected

Elaine Tan

Medical DeviceMedical Device

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Dec 31, 2025

🍜 China Regulatory 2025 Wrap Up

What changed in 2025?

Elaine Tan

RegistrationRegistration

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Dec 15, 2025

🍜 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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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

Nov 13, 2025

🍜 New China's GMP Update

How China's GMP differs from ISO 13485?

Elaine Tan

RegistrationRegistration

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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

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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

Oct 01, 2025

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

China’s New Self-testing Guidance Explained

Elaine Tan

ClinicalClinical

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Sep 18, 2025

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

How Hainan became China’s medtech pilot zone

Elaine Tan