MDSAR 2021
Medical Device Supervision and Administration Regulations 2021 医疗器械监督管理条例 (State Council Order No. 739)
MDSAR 2021 is China's primary medical device regulation. It came into force on 1 June 2021, replacing the 2017 version. It is a State Council (国务院) regulation — one level below national law in the Chinese legal hierarchy, but binding on all parties in the supply chain.
Structure
MDSAR 2021 has 8 Chapters and 107 Articles:
| Chapter | Title | Key articles |
|---|---|---|
| I | General Provisions | Arts. 1–9: Purpose, definitions, jurisdiction |
| II | Medical Device Registration and Filing | Arts. 10–43: Registration obligations by class, China Agent, dossier requirements, certificate |
| III | Medical Device Production | Arts. 44–57: Production licence, GMP, quality system |
| IV | Medical Device Operation | Arts. 58–72: Business licence, storage, traceability, advertising |
| V | Medical Device Supervision and Administration | Arts. 73–80: NMPA powers, market surveillance, inspection |
| VI | Adverse Event Monitoring and Re-evaluation | Arts. 81–87: Reporting, PMS, recalls |
| VII | Legal Liability | Arts. 88–101: Penalties for violations |
| VIII | Supplementary Provisions | Arts. 102–107: Definitions, effective date |
Key articles
| Article | Subject |
|---|---|
| Art. 13 | Class I filing requirement |
| Art. 14 | Class II registration requirement |
| Art. 15 | Class III / imported registration requirement |
| Art. 39 | China Agent mandatory requirement and joint liability |
| Art. 44 | Production licence requirement (Class II/III) |
| Art. 76 | Definitions — medical device, IVD, registrant |
| Arts. 88–101 | Penalty provisions |
Official text
MDSAR 2021 full text: State Council Order No. 739 (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.