Elaine Tan

Elaine Tan

Medical DeviceMedical Device
+1+1
🍜 The China Launch Timeline Trap

🍜 The China Launch Timeline Trap

What you should know before promising customers or investors

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China Monthly Regulatory Signals

🍜 China Monthly Regulatory Signals

March 2026: Regulation, guidance, standards watchlist

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China Expands UDI Implementation

🍜 China Expands UDI Implementation

Timelines, exemptions, and special scenarios

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China Monthly Regulatory Signals

🍜 China Monthly Regulatory Signals

February 2026: Direction, guidance, standards watchlist

Elaine Tan
ClinicalClinical
+2+2
🍜 The China Clinical Trap

🍜 The China Clinical Trap

Common Mistakes of Manufacturers in Clinical Strategy

Elaine Tan
Medical DeviceMedical Device
+1+1
🍜 China Medtech: What You Missed in January

🍜 China Medtech: What You Missed in January

Catalogue updates, new guidance, standards watchlist

Elaine Tan
RegistrationRegistration
+2+2
🍜 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
+1+1
🍜 China Regulatory 2025 Wrap Up

🍜 China Regulatory 2025 Wrap Up

What changed in 2025?

Elaine Tan
RegistrationRegistration
+2+2
🍜 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
+2+2
🍜 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