Authors: Huang Jianwen, Zhang Yu, Regulatory & Compliance Group, King & Wood Mallesons

Medical devices are related to the life and health of the people and the overall situation of the country’s social development. With the rapid development of China’s medical device industry, Regulations on Supervision and Administration of Medical Devices, as the “Basic Law” of the industry’s supervision, has undergone two amendments in 2014 and 2017 since its promulgation in 2000. On October 8, 2017, the General Office of the Central Committee of the CPC and the General Office of the State Council issued the Opinions on Deepening the Reform of Evaluation and Approval System and Encouraging Innovations in Drugs and Medical Devices (the “Opinions on Deepening the Reform and Encouraging Innovations”), which put forward new requirements for deepening the reform of evaluation and approval system of medical devices. In order to adapt the rapid development of the medical device industry and the further reform of the regulatory system of industry, the newly revised Regulations on the Supervision and Administration of Medical Devices (the “New Regulations”) was adopted by the Decree of State Council (No. 739) and signed by the Premier of the State Council on February 9, 2021. The New Regulations have been implemented since June 1, 2021.

Compared with Regulations on Supervision and Administration of Medical Devices (2017 Amendment) (the “2017 Edition of the Regulations”), the New Regulations pay more attention to promoting the innovative development of the medical device industry, and simultaneously focus on the quality and safety of medical device products.  Through the study of the New Regulations, we understand that the New Regulations are mainly amended in the following five aspects: (1) establishing a system of medical device registrant and filing applicant to promote the full implementation of the system of market authorization holders and to consolidate the responsibilities of enterprises; (2) consolidating the achievement of the reform and comprehensively optimize the approval and record-filing procedures; (3) encouraging innovation of medical devices and treating the innovation of medical devices as the focus of development; (4) clarifying the regulatory requirements for hot issues such as online distributions of medical devices; (5) adjusting the legal liabilities to increase the number of penalty circumstances and increase the penalty for illegal acts.

This article will interpret the main contents and the highlights of the amendment of the New Regulations, and analyze the changes in China’s medical device regulatory system under the New Regulations and its impact on the industry development. Continue Reading Optimizing Supervision System and Promoting Industrial Development – Interpretation of Key Points of Regulations on Supervision and Administration of Medical Devices (2021 Amendment)