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 2000 Medical Device Supervision and Administration Regulation. It is a State Council (国务院) regulation — the second-highest tier of binding administrative legislation in China's legal hierarchy — and is binding on all manufacturers, distributors, healthcare institutions, and regulatory bodies 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: Supplementary Provisions, including interpretation authority, transitional measures for devices registered under previous regulations, and effective date (1 June 2021)
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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