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Administrative Penalties

This page provides a plain English reference for administrative penalties under China's NMPA enforcement framework. Full content to be completed during editorial review.

Regulatory basis​

NMPA enforcement authority and penalties are provided under:

  • MDSAR 2021 Chapter VII (Legal Liability β€” Articles 88–101) β€” establishes penalty framework, amounts, and enforcement procedures
  • Medical Device Operation Supervision and Administration Measures (NMPA Order No. 54) β€” details operational compliance requirements and enforcement mechanisms for manufacturers, distributors, and users
Disclaimer

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.

MDSAR 2021 Chapter VII authorizes NMPA and local authorities to impose administrative penalties including: warnings, confiscation of illegal devices and proceeds, fines (up to RMB 3 million for serious violations), suspension or revocation of registration certificates, and public disclosure of violations. Penalties vary based on violation severity and intent.