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, scope, definitions, NMPA jurisdiction II Medical Device Registration and Filing Arts. 10–43: Registration and filing by class, China Agent, dossier requirements, certificate issuance and validity III Medical Device Production Arts. 44–57: Production licence requirement and exemptions, GMP compliance, quality system IV Medical Device Operation Arts. 58–72: Business licence, storage and transportation, traceability, distribution, advertising restrictions V Medical Device Supervision and Administration Arts. 73–80: NMPA authority, market surveillance, inspection and sampling VI Adverse Event Monitoring and Re-evaluation Arts. 81–87: Adverse event reporting, post-market surveillance, risk re-evaluation, recalls and corrections VII Legal Liability Arts. 88–101: Administrative and criminal penalties for violations VIII Supplementary Provisions Arts. 102–107: Interpretation, transitional provisions, effective date
Key articles
Arts. 102–107 Definitions and effective date (Chapter VIII Supplementary Provisions includes key definitions; primary definitions are found in Arts. 1-9 Chapter I General Provisions)
Official text
MDSAR 2021 full text: State Council Order No. 739 (gov.cn)
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