🍜Journey of Innovative Medical Devices

What makes China’s pathway different from the US?

🍜 China’s 2025 Update on Clinical Evaluation Exemption

Is your device on the list?

🍜 China PMS (Part 3): Reassessment Rules Explained

When, what, and how you must report to NMPA

🍜 Post-market Surveillance (Part 2)

🍜 Post-market Surveillance (Part 1)

🍜 Potential Changes to China's Medical Device Classification Rules

New draft rules sharpen the line between Class I and Class II devices

🍜 An Alternative to Accredited Laboratory Tests?

How to get your medical device tested in China

🍜Your Blueprint to the Product Technical Requirements (PTR)

🍜Mandatory or Recommended Chinese Standards

Demystifying China’s Medical Device Standards

🍜 Secure Made‐in‐China Approval by Moving Production to China

🍜Clinical Evaluation Routes for Medical Devices in China