Efforts will be made to enhance the positive role of medical device standards in supporting scientific supervision,promoting high-tech innovation,promoting high-level openness,and leading high-quality development.
1、Overview of Medical Device Standard Data
（1）Data issued for the revision plan of medical device standards
1.National standard revision plan.In 2023,the National Standards Committee approved the issuance of 52 national medical device standard project plans.According to the division of standard formulation and revision,34 items(65.4%)were formulated and 18 items(34.6%)were revised;According to the nature of the standards,there are 4 mandatory standard plans(accounting for 7.7%),46 recommended standard plans(accounting for 88.5%),and 2 guiding technical d0cuments(accounting for 3.8%).
2.Industry standard revision plan.In 2023,the National Medical Device Administration approved and issued 117 plans for the establishment of medical device industry standards.According to the division of standard formulation and revision,57 plans(48.7%)were formulated and 60 plans(51.3%)were revised;According to the nature of the standards,there are 15 mandatory standard plans(accounting for 12.8%)and 102 recommended standard plans(accounting for 87.2%),among which 22 enterprise led standard projects(accounting for 18.8%).
（2）Medical device standard approval release data
1.National standards.In 2023,the National Standards Committee approved the release of 28 national standards for medical devices.According to the division of standard formulation and revision,13 standards were formulated(accounting for 46.4%)and 15 standards were revised(accounting for 53.6%);According to the nature of the standards,there are 5 mandatory standards(accounting for 17.9%),21 recommended standards(accounting for 75.0%),and 2 guiding technical d0cuments(accounting for 7.1%).
2.Industry standards.The National Medical Products Administration has approved the release of 131 industry standards for medical devices.According to the division of standard formulation and revision,68 standards(51.9%)have been formulated and 63 standards(48.1%)have been revised;According to the nature of the standards,there are 33 mandatory standards(accounting for 25.2%)and 98 recommended standards(accounting for 74.8%).Release 14 amendment forms for medical device industry standards.
（3）Current medical device standard data
1.Standard overall data
As of December 31,2023,there are a total of 1974 effective medical device standards,including 271 national standards and 1703 industry standards(see table below).
From 2019 to 2023,the number of national and industry standards showed a stable upward trend year by year(see Figure 1).
2.Standard classification data
According to standard specifications,there are 330 basic standards in the current effective medical device standards,accounting for 16.7%of the total;51 management standards,accounting for 2.6%;480 method standards,accounting for 24.3%;There are 1113 product standards,accounting for 56.4%(see Figure 2).25 basic standards will be released in 2023,accounting for 15.7%;7 management standards,accounting for 4.4%;36 method standards,accounting for 22.6%;There are 91 product standards,accounting for 57.3%(see Figure 3).
According to the classification and statistics of the Chinese Standard Literature Classification System,the current effective medical device standards comprehensively cover various technical fields of medical devices,mainly concentrated in medical laboratory equipment C44(accounting for 14.3%),comprehensive medical device C30(accounting for 11.3%),orthopedic and orthopedic instruments C35(accounting for 10.8%),and general and microsurgical instruments C31(accounting for 10.4%);The standards released in 2023 cover 16 categories of standards,including comprehensive C30 for medical devices and C33 for dental devices,equipment and materials.The number of comprehensive standards for medical devices is the highest,accounting for 20.9%of the standards released that year.The distribution of the proportion of standards in various fields is shown in Figure 4-5.
（4）Standard technical organization data
In 2023,the National Standards Commission established the National Medical Protective Device Standardization Working Group(SAC/SWG30),and the National Medical Products Administration approved the establishment of a centralized technical unit for standardization of reliability and maintainability of medical devices(SMD/TU009)and a centralized technical unit for standardization of digital oral medical devices(SMD/TU010).It also approved the establishment of a centralized technical unit for standardization of medical device packaging.As of December 31,2023,there are a total of 38 medical device standard technical organizations,including 13 general standard committees(TC),13 sub standard committees(SC),2 standardization working groups,and 10 technical centralized units(see Figure 6).
2、Key tasks of medical device standards
（1）Strengthening the Foundation of the Standard System
In 2023,the National Medical Products Administration revised and released the Work Rules for the Approval and Release of Medical Device Standards,further standardizing the approval and release of medical device standards;The Organization Device Standard Management Center shall formulate and issue the"Principles for Determining National and Industry Standards for Medical Devices"and"Principles for Determining Compulsory Standards for Medical Devices",clarifying the hierarchy and scope of standards;Develop and issue the"Detailed Rules for the Implementation and eva1uation of Medical Device Standards"and the"Feedback and Handling Mechanism for Medical Device Standards"to address the"last mile"issue of standard implementation;Issuing the"Work Norms for Enterprises Leading the Drafting of Recommended Industry Standards for Medical Devices(Trial)",clarifying the responsibilities and requirements for enterprises leading the revision of standards,and further improving the standard system for promoting the high-quality development of medical devices.
（2）Building a three-dimensional support structure for a standard organizational system
According to the corresponding situation of the International Organization for Standardization,the National Medical Device Quality Management and General Requirements Standardization Technical Committee will be organized to form a working group on connectors for small aperture and storage container transportation systems for liquid and gas medical devices.The National Surgical Implants and Orthopedic Devices Standardization Technical Committee will be organized to form an additive manufacturing implant device standard working group,an implant ceramic material standard working group,and an implant metal material standard working group Four working groups,including the Working Group on Polymer Materials Standards,have established a three-dimensional organizational structure for medical device standards,which includes horizontal(General Standards Committee,Working Group,and Responsible Unit)to the edge,vertical(Sub Standards Committee)to the bottom,and vertical(Working Group directly under the Standards Committee)support.
（3）Prepare technical reserves for epidemic prevention and control standards in the new stage
In 2023,we will closely monitor the prevention and control of monkeypox virus and organize the application for the national standard"Quality eva1uation Requirements for Monkeypox Virus Nucleic Acid Testing Kits"to standardize the production and quality control of monkeypox virus nucleic acid testing kits;We organized the translation of five national standards in foreign languages,including Quality eva1uation Requirements for novel coronavirus Nucleic Acid Test Kits,Quality eva1uation Requirements for novel coronavirus Antibody Test Kits,Quality eva1uation Requirements for novel coronavirus IgG Antibody Test Kits,Quality eva1uation Requirements for novel coronavirus Antigen Test Kits,and Quality eva1uation Requirements for novel coronavirus IgM Antibody Test Kits,To lay a solid technical foundation for the prevention and control of COVID-19 epidemic in China.
（4）Fully complete the dual coverage assessment and eva1uation of the Standards Committee
To further strengthen and standardize the management of the Standards Committee,organize and complete the assessment and eva1uation work of the Standards Committee that covers both the scope of objects and the content of indicators.The scope of the eva1uation fully covers the 32 standardization committees established before January 1,2020 and have carried out standardization work during the eva1uation year.The content of the eva1uation indicators fully covers the standard management and approval standard quality of the eva1uation year.Strictly in accordance with the requirements of the assessment and eva1uation rules,expert review and cross review methods are adopted to conduct a comprehensive eva1uation of the standardization work of the Standards Committee from 2021 to 2022,including all elements,contents,and chains.Quantitative assessment indicators are used to report assessment results,directly address problems and difficulties,fill gaps,and solve problems.By strengthening"hard constraints","soft power"is enhanced.
（5）Enterprise led industry standard revision and continued efforts
In order to fully leverage the leading role of enterprises in standard formulation and revision,and encourage the initiative of enterprises to take the lead in drafting medical device industry standards,the National Medical Products Administration will pilot the public solicitation of six first drafting units for medical device standards in 2022,exploring the establishment of a mechanism for enterprises to lead the drafting of recommended industry standards.In 2023,the Work Norms for Enterprise led Drafting of Recommended Industry Standards for Medical Devices(Trial)were issued,and 22 tasks for enterprise led standard formulation and revision were assigned.The work mode of enterprise led and guided by the Standards Committee was initially established,and the enterprise led drafting of industry standards gradually transitioned from pilot to demonstration led.
（6）Standardize the promotion of standard review and implementation eva1uation
Standardized standard review and standard implementation eva1uation is an important means to improve the quality of standards and ensure the effectiveness,progressiveness and applicability of standards.In 2023,the National Medical Products Administration will further strengthen the requirements for standard review work and accelerate the construction of the standard implementation eva1uation system.Complete the review of 942 current medical device standards and propose the review conclusion;Organize the implementation eva1uation of 45 typical standards and form an implementation eva1uation work report.In August 2023,Shandong Medical Device and Drug Packaging Inspection and Research Institute and Hubei Medical Device Quality Supervision and Inspection Research Institute were successfully approved as the first batch of national mandatory standard implementation statistical analysis points(medical devices).The statistical analysis points will monitor and eva1uate the entire process of implementing mandatory national standards in key areas,establish a scientific,accurate,and comprehensive implementation eva1uation system,and help to further upgrade the quality of medical device standards.
（7）Establish a standard update mechanism that quickly links with international standards
The standardization work of medical devices in our country has always adhered to the work goal of"based on national conditions,facing the international market,and benchmarking against advanced".For international standards that are suitable for transformation according to our national conditions,close tracking,early research,and synchronous transformation should be carried out.In principle,the international standards should be transformed within 2 years after their release.In 2023,a total of 66 national and industry standards for medical devices have been released that adopt international standards.The project plan for converting 86 international standards for medical devices into national or industry standards in China has been approved and issued,and the consistency of international standards for medical devices has reached over 90%.
（8）The internationalization process of medical device standards is accelerating
In 2023,China led the development of the international standard"Test Method for Aerosol Bacterial Interception of Intake Devices for Infusion Devices"(standard number ISO 24072:2023),which was officially released.The international standard proposal"Algorithm Performance Test Method for Pulmonary Imaging Assisted Analysis Software of Artificial Intelligence Medical Devices"(project number IEC 63524 ED1)was successfully approved.The revision of 6 international standards and the transformation of 9 foreign language versions of medical device standards are steadily progressing,Recommend 2 Chinese experts to be successfully elected as the Chairman of IEC SC 62B and Vice Chairman of IEC TC62.Organize and participate in a total of 52 international standard conferences,represent China in 129 international standard voting sessions with corresponding international standardization organizations,and add 8 registered experts to the International Organization for Standardization.The internationalization of medical device standards has shifted from integration to integration.
（9）Actively creating a standardized and positive social atmosphere
In 2023,we successfully held the 54th World Standard Day themed promotion event on"Standardizing and Innovating Devices to Help Health".We organized various forms of activities such as consultation days,symposiums,keynote speeches,and standardization for enterprises,widely promoting and popularizing standardization concepts throughout society,and consolidating standardization consensus;At the same time,organize comprehensive knowledge training courses on medical device standards and special exchange and reporting meetings on standard work,promote standardization regulations and policies,and share standardization work experience;Print internal communication materials for the second issue of"Scientific and Research on Medical Device Standards"to provide a convenient platform for scientific research and academic exchange on medical device standards.
（10）Consistent standard service philosophy
The life of standards lies in implementation.The standardization of medical devices has always adhered to the service concept,continuously increased the transparency of standards to ensure their accessibility,strengthened standard training to guide the standardized use,and promoted the effective implementation of standards.In 2023,179 draft standards were publicly solicited for comments,1283 mandatory medical device industry standards and non standardized recommended industry standard texts were publicly disclosed,the 2023 version of the"Catalogue of Medical Device Standards"was publicly released,a column for medical device standard training and interpretation was opened,140 medical device standard interpretations were publicly released,75 new GB 9706 series standard training videos were publicly released,with over 1.5 million views.203 medical device standards were organized for promotion and training,The new version of GB 9706 standard public welfare training course has more than a thousand participants.