9 docs tagged with "registration"

The Class I medical device filing process with district or municipal authorities in China.

The Class II medical device registration process with provincial NMPA bureaux in China.

The Class III medical device registration process with national NMPA and CMDE technical review.

How overseas manufacturers register medical devices in China through a China Agent.

Registration pathway for in vitro diagnostic reagents under NMPA Order No. 48.

China medical device registration certificate — validity, scope, changes, and re-registration.

Technical documentation requirements for medical device registration in China.

When 注册 (registration) vs 备案 (filing) applies — the two market entry pathways for medical devices in China.

How CMDE reviews Class III and imported medical device registration dossiers.