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.
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
- NMPA Announcement No. 52/2026 (effective 1 June 2026) — establishes procedural framework for managing classification-reclassification adminis