On February 18, the State Food and Drug Administration released the “China Medical Device Standard Management Annual Report (2021)” (hereinafter referred to as the “Annual Report”). The “Annual Report” shows that in 2021, 35 national standards for medical devices and 146 industry standards for medical devices were released nationwide, and the number of national standards released has increased significantly. 与此同时，我国积极参与国际标准制修订，由我国主导制定的2项国际标准正式发布。 Our country has established a long-term mechanism for standards management, optimized the working mechanism for standard formulation and revision, guided all parties to actively participate in the standard formulation and revision work, improved the standard implementation feedback mechanism, and formed a closed-loop management of the entire standard formulation and revision chain.
In 2021, the State Food and Drug Administration integrated resources from all parties and actively promoted the establishment of standardization technology organizations in areas of urgent need for supervision and innovation. It has successively approved the establishment of two standardized technology focal points for national medical device clinical evaluation and medical high-throughput sequencing, further improving the standard organizational structure.
In terms of developing epidemic prevention and control standards, my country has organized and formulated five recommended national standards, including the “Quality Evaluation Requirements for Novel Coronavirus Nucleic Acid Detection Kits” and “Quality Evaluation Requirements for Novel Coronavirus Antigen Detection Kits”, to provide technical support for the quality evaluation of new coronavirus detection reagents in terms of nucleic acid, antigen and antibody detection. my country actively supports international epidemic prevention and control. The first international standard project for medical devices for COVID-19 epidemic prevention and control proposed and completed by my country was released, filling the gap in international standards for related products.
In 2021, a total of 181 medical device standards were released nationwide, and the number of standards released increased by 21% compared with the previous year. At the same time, the standard system structure is more optimized, the coverage area is more comprehensive, and the effectiveness of the standard is enhanced. The State Food and Drug Administration focuses on supporting the formulation of basic general and urgently needed standards for supervision. Among the 35 national standards released in 2021, 18 are a series of special safety standards supporting medical electrical equipment GB 9706.1, 5 are new coronavirus detection reagent quality evaluation requirements, 6 are a series of standards for clinical laboratory medical laboratory quality and capability requirements, and 2 are a series of basic general standards for biological evaluation of medical devices. Basic general standards and urgently needed standards for epidemic prevention and control and supervision account for 89%. On the basis of optimizing the assessment of existing mandatory standards for medical devices, my country has strictly limited the incremental mandatory standards for medical devices to those involving basic safety, performance requirements, basic general technical requirements related to safety, and relevant requirements related to the “Basic Principles of Safety and Performance of Medical Devices”. In 2021, a total of 41 mandatory standards for medical devices were released, including 17 national standards and 24 industry standards.
In terms of participating in the formulation and revision of international standards, two international standards led by my country were officially released. In addition to the above-mentioned international standards for medical devices for the prevention and control of the new coronavirus epidemic, the first international standard I SO 22679-2021 “Cardiovascular Implants-Cardiac Occluder” transformed from my country’s medical device industry standard (Standard No.: YY/T 1553-2017) was officially released in November 2021. The release of this international standard marks that my country’s medical device standards have gradually begun to explore the promotion of my country’s standards to the world on the basis of continuing to improve the consistency with international standards. In addition, our country is also actively developing new international standard projects, promoting the formulation of international standards, and participating in international standardization activities.