5 docs tagged with "enforcement"

Administrative penalty tiers under MDSAR 2021 — fines, suspension, revocation, and personal liability.

China's regulatory blacklist and cross-agency consequences for serious NMPA violations.

NMPA and Customs co-ordination for import control of non-compliant medical devices into China.

NMPA and local bureau spot-checks, product sampling, and post-market surveillance activities in China.

Types of NMPA inspection, inspection rights, and documentation requirements for medical device companies in China.