Basic Information on the Document

The Regulations on the Supervision and Administration of Medical Devices were revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020, promulgated by State Council Order No. 739, and took effect on June 1, 2021. The Regulations superseded the 2014 revised version (State Council Order No. 650) and apply to all parties engaged in "the research and development, manufacturing, distribution and use of medical devices within the territory of the People's Republic of China, and the supervision and administration thereof."

Risk-Based Classification Management System

The Regulations classify medical devices into Class I, Class II and Class III according to the degree of product risk, and implement differentiated management: Class I products are subject to product filing, while Class II and Class III products are subject to product registration. The overall regulatory principles are "risk management, full-process control, science-based regulation, and social co-governance."

Framework of Main Contents

The Regulations comprise eight chapters, covering: product registration and filing (standardizing clinical evaluation and clinical trial procedures); manufacturing management (manufacturing condition requirements, quality management systems, and contract manufacturing standards); distribution and use management (operating qualification requirements, incoming inspection, online sales standards, and the responsibilities of using entities); adverse event handling and recalls (the monitoring system, the recall system, and the re-evaluation mechanism); and a tiered penalty system.

Special Provisions on Single-Use Devices

The Regulations expressly require that single-use medical devices must not be reused, and that used ones shall be destroyed and recorded in accordance with relevant state regulations. The catalogue of single-use medical devices is formulated, adjusted and published by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.

Source: State Council, Order of the State Council of the People's Republic of China (No. 739) — Regulations on the Supervision and Administration of Medical Devices, Gazette of the State Council on the Chinese Government Website, https://www.gov.cn/gongbao/content/2021/content_5595920.htm