🍜 Post-market Surveillance (Part 1)

Yoour Obligations as a Registration Holder

🍜 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

🍜Device Exempt from Clinical Evaluation?

Clinical Trial vs Clinical Trial Exemption in China

🍜 Navigating the NMPA Registration Process: Timelines, Costs, and Considerations

🍜 Potential Changes to the In-Country Agent Role in China in 2025