White paper · NMPA clinical evaluation
NMPA Clinical Evaluation Pathways for Overseas Medical Device Manufacturers
A practical guide to choosing the clinical evaluation route for China, with a comparison of the rules in China, Australia and New Zealand.
What the white paper covers
- The three NMPA clinical evaluation routes: exemption catalogue, same-variety comparison and clinical trial data
- A step-by-step decision path for choosing the route
- China, Australia and New Zealand compared, including New Zealand’s planned Medical Products Bill
- How to use existing EU MDR, US FDA and TGA evidence for an NMPA submission
- The problems NMPA reviewers raise most often, and a worked example of a representativeness argument
- A preparation checklist
Who it is for
Regulatory, clinical and market access teams at medical device manufacturers planning to register in China, and consultancies that support them.
Request the white paper
Fill in the form and we will email you the download link.
We use your details only to send the white paper and to contact you about related services, as described in the consent statement. You can ask us to stop or to delete your details at any time by emailing vincent_yu@bbm.co.nz.