Archive

Medical DeviceMedical Device
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🍜 The China Launch Timeline Trap

🍜 The China Launch Timeline Trap

What you should know before promising customers or investors

Elaine Tan
Medical DeviceMedical Device
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🍜 China Monthly Regulatory Signals

🍜 China Monthly Regulatory Signals

March 2026: Regulation, guidance, standards watchlist

Elaine Tan
Medical DeviceMedical Device
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🍜 China Expands UDI Implementation

🍜 China Expands UDI Implementation

Timelines, exemptions, and special scenarios

Elaine Tan
Medical DeviceMedical Device
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🍜 China Monthly Regulatory Signals

🍜 China Monthly Regulatory Signals

February 2026: Direction, guidance, standards watchlist

Elaine Tan
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
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