Upcoming Changes
This page lists known future regulatory deadlines and anticipated changes in China's medical device regulatory framework.
UDI implementation deadlinesβ
China's UDI implementation is phased by device class:
| Device class | Obligation | Deadline |
|---|---|---|
| Class III | UDID submission mandatory | Implemented (2019 pilot onwards) |
| Class II | UDID submission mandatory | Phase-in ongoing β verify current status with NMPA |
| Class I | UDID submission | Phase-in ongoing β verify current status with NMPA |
Always verify current UDI deadlines directly with NMPA, as dates have been extended multiple times. See UDI Implementation Timeline.
Registration certificate renewalsβ
Monitor the 5-year expiry dates of your NMPA registration certificates. Re-registration applications should be submitted at least 6 months before expiry. See Re-Registration.
Legislative updatesβ
Known pending legislative changes to be added as confirmed from official sources.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.