RAPath CN
China Medical Device Regulatory Reference — NMPA & MDSAR 2021
RAPath CN is a plain English reference for China medical device regulation under the Medical Device Supervision and Administration Regulations 2021 (MDSAR 2021 — 医疗器械监督管理条例, State Council Order No. 739) and its implementing measures. It is designed for regulatory affairs professionals, manufacturers, importers, China Agents, distributors, and consultants navigating the National Medical Products Administration (NMPA — 国家药品监督管理局) framework.
This site does not replace official NMPA sources. Every page links back to the authoritative legislative text or official NMPA guidance. Think of RAPath CN as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative or regulatory source.
Manufacturers (China and overseas) — understand what MDSAR 2021 requires of you, including product registration or filing obligations, GMP compliance, and post-market surveillance.
Importers and their China Agents (代理人) — understand the mandatory China Agent role, joint liability obligations, and how the agent framework differs from EU Authorised Representatives or FDA US Agents.
Distributors and hospitals — understand distribution traceability, dealer obligations, and implantable device tracking requirements.
Anyone new to China medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device in China:
| Section | What it covers |
|---|---|
| Start Here | Definitions, three-tier authority structure, China Agent introduction, lifecycle, glossary |
| Pre-Market | Classification (Class I–III, IVD), registration vs filing, CMDE review, clinical evidence, special device types |
| Post-Market | Adverse event reporting, annual reports, PMS, recalls, labelling, re-registration |
| Quality System (GMP/QMS) | MDSAR 2021 GMP, YY/T 0287 (ISO 13485 equivalent), design controls, CAPA, NMPA inspections |
| China Agent (代理人) | Mandatory agent role for imported devices — obligations, selection, liability, comparison with other frameworks |
| UDI | China UDI system, NMPA UDI database (UDID), encoding rules, phased implementation timeline |
| Legislation & Regulations | MDSAR 2021, NMPA implementing measures, YY/T standards, key announcements |
| Guidance Documents | NMPA and CMDE technical guidance indexed by topic |
| International & Comparison | IMDRF alignment, China vs FDA/EU/TGA/HSA, multi-market strategy |
| Digital Health & SaMD | SaMD classification, AI/ML NMPA policy, cybersecurity |
| Special Access | Priority review, innovative device designation, emergency use, Hainan FTP pilot |
| Enforcement & Compliance | NMPA inspections, penalties, market surveillance, blacklist |
| What's New | Recent regulatory changes, draft guidance, upcoming deadlines |
What this site is not
- Not legal or regulatory advice. Always consult qualified regulatory counsel before making submission or compliance decisions.
- Not affiliated with NMPA. This site is not produced by or on behalf of the National Medical Products Administration.
- Not a substitute for official sources. Every page links to the relevant NMPA guidance or MDSAR provision — always verify there.
Content currency
This site was last reviewed in May 2026. NMPA regulations and guidance change frequently. Check What's New for recent updates.
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.