9 docs tagged with "legislation"

GCP requirements and sponsor obligations for medical device clinical trials in China.

NMPA adverse event monitoring measures — reporting thresholds, periodic reporting, and recall powers.

NMPA Order No. 48 — registration and filing measures specific to in vitro diagnostic reagents.

Annotated index of significant NMPA orders and announcements since 2021.

Structure and key articles of the MDSAR 2021 (State Council Order No. 739) — China's primary medical device regulation.

NMPA Order No. 54 — distribution, storage, and traceability obligations for medical devices in China.

NMPA Order No. 53 — GMP and production supervision measures for medical device manufacturers.

NMPA Order No. 47 — registration and filing administration measures for medical devices in China.

YY/T medical device standards and GB national standards — mandatory vs recommended in China.