Device classification
Class I, II or III — the decision that shapes the whole project
The NMPA classifies medical devices into three classes by risk. The class determines whether the device is filed or registered, which authority handles it, whether clinical evidence is needed, and how long the route takes.
A classification opinion obtained early is the cheapest part of an NMPA project and the one that most often changes the plan.
What this covers
- Classification against the China medical device classification catalogue
- Comparison with the classification the device holds in other markets
- Product naming aligned with the China naming rules
- Route and timeline plan based on the resulting class
- Support where the classification is unclear or contested
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