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Key NMPA Orders and Announcements

This page provides a plain English reference for key nmpa orders and announcements in China's medical device regulatory framework. Full content to be completed during editorial review.

Overview​

See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.

Official source​

Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.

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.

Overview​

NMPA issues orders, announcements, and guidance documents that implement and clarify MDSAR 2021 and related measures. These are binding directives or guidance materials affecting device registration, post-market surveillance, and compliance.

Key Orders and Announcements​

  • NMPA Announcement 2021-01: Medical Device Registration and Filing Procedure (implementing MDSAR 2021 Chapter II)
  • NMPA Announcement on Good Manufacturing Practice: QMS and production requirements under MDSAR 2021 Chapter III
  • NMPA Post-Market Surveillance Guidance: Procedures for manufacturer-led safety monitoring
  • NMPA Adverse Event Reporting Guideline: Detailed reporting procedures and timeframes
  • NMPA Recall Procedure: Manufacturer notification and implementation requirements

Official Source​

All NMPA orders and announcements are published on www.nmpa.gov.cn under the 'Announcements' and 'Guidance Documents' sections.