China FDA issues final classification rules on medical devices

The China FDA has issued revised and final medical device classification rules set to go into effect at the start of next year. The final rules categorize the level of risk posed by devices by noting structural features, intended use, and whether they involve human contact. There are four primary categories for classification: passive, active, invasive, and reusable surgical devices, as well as a special classification category for combination devices. Release (Chinese language)