I. Data overview of medical device standards

(i) Release data on formulation and revision plan of medical device standards

1. Formulation and revision plan of national standards. In 2023, the Standardization Administration approved and issued 52 national standard projects for medical devices, which were divided into formulation projects (34, 65.4%) and revision projects (18, 34.6%) according to the formulation and revision of standards; they were divided into mandatory standard projects (4, 7.7%), recommended standard projects (46, 88.5%), and guiding technical document projects (2, 3.8%) according to the nature of the standards.

2. Formulation and revision plan of industry standards. In 2023, China NMPA approved and issued 117 industry standard projects for medical devices, which were divided into formulation projects (57, 48.7%) and revision projects (60, 51.3%) according to the formulation and revision of standards; they were divided into mandatory standard projects (15, 12.8%) and recommended standard projects (102, 87.2%) according to the nature of the standards, of which 22 enterprise-led standard projects (18.8%).

(ii) Data on issuance of approval of medical device standards

1. National standards. In 2023, the Standardization Administration approved and released 28 national standard projects for medical devices, which were divided into formulation projects (13, 46.4%) and revision projects (15, 53.6%) according to the formulation and revision of standards; they were divided into mandatory standard projects (5, 17.9%), recommended standard projects (21, 75.0%), and guiding technical document projects (2, 7.1%) according to the nature of the standards.

2. Industry standards. China NMPA approved and released 131 industry standard projects for medical devices, which were divided into formulation projects (68, 51.9%) and revision projects (63, 48.1%) according to the formulation and revision of standards; they were divided into mandatory standard projects (33, 25.2%) and recommended standard projects (98, 74.8%) according to the nature of the. 14 amendments to medical device industry standards were released.

(iii) Data on current medical device standards

1. Overall data on standards

As of December 31, 2023, China has a total of 1974 currently effective medical device standards, including 271 national standards and 1703 industry standards.

From 2019 to 2023, the number of national and industry standards has shown a steady upward trend year by year.

2. Data on standard category

According to the statistics of standardized objects, there were 330 basic standards (16.7%), 51 management standards (2.6%), 480 method standards (24.3%), and 1113 product standards (56.4%) in the currently effective medical device standards. In 2023, 25 basic standards (15.7%), 7 management standards (4.4%), 36 method standards (22.6%), and 91 product standards (57.3%) were issued.

According to the classification statistics specified in the Chinese Classification for Standards, the currently effective medical device standards comprehensively covered all technical fields of medical devices, mainly focusing on C44 Medical laboratory equipment (14.3%), C30 Medical apparatus and devices in general (11.3%), C35 Orthopedic devices (10.8%), and C31 General and microsurgical devices (10.4%). In 2023, the published standards covered 16 standard categories such as C30 Medical apparatus and devices in general, C33 Stomatologic device, equipment and material, etc. Medical apparatus and devices in general hold the distinction of having the largest number of published standards, accounting for 20.9% of the published standards in that year.

(iv) Data on standard technical organizations

In 2023, the Standardization Administration established the National Standardization Working Group for Medical Protective Devices (SAC/SWG30), China NMPA approved the establishment of the Standardized Technical Authorized Organization for Reliability and Maintainability of Medical Devices (SMD/TU009) and the Standardized Technical Authorized Organization for Oral Digitized Medical Devices (SMD/TU010), and approved the preparations for the establishment of the Standardized Technical Authorized Organization for the Standardization of Medical Device Packaging. As of December 31, 2023, there were a total of 38 medical device standard technical organizations, including 13 general standardization committees (TCs), 13 subcommittees for standards (SCs), 2 standardization working groups, and 10 technical authorized organizations.

II. Focus on medical device standards

(i) Solid foundation of standard system

In 2023, China NMPA took several measures to further standardize the approval and release of medical device standards. These efforts included the revision and issuance of the Working Rules for the Approval and Release of Medical Device Standards, as well as the organization of the Center for Medical Device Standardization Administration to formulate and issue the Principles for Determining National and Industry Standards for Medical Devices and Principles for Determining Mandatory Standards for Medical Devices to clarify the level and scope of standards. Additionally, China NMPA formulated and issued the Working Rules for the Evaluation of Medical Device Standard Implementation and the Feedback and Processing Mechanism for Medical Device Standard Opinions to solve the "problems faced in the final actual implementation" during standard implementation. Furthermore, China NMPA issued the Guidelines for Enterprises to Lead the Drafting of Recommended Industry Standards for Medical Devices (Trial) to outline the responsibilities and requirements for enterprises to take the lead in standard formulation and revision, with the goal of promoting the high-quality development of medical devices.

(ii) Constructing a three-dimensional support structure for the standard organization system

According to the counterparts with the International Organization for Standardization, China NMPA has taken steps to establish the National Technical Committee on Quality Management and General Requirements for Medical Device of Standardization Administration of China to set up the Working Group for Connectors for Liquid and Gas with Small Aperture and Liquid Receiver Delivery System for Medical Devices, and organized the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices to set up the Working Group for Additive Manufacturing of Implantable Devices, the Working Group for Ceramic Implantation, the Working Group for Implantation of Metallic Materials, and the Working Group for Implantation of Polymer Materials, etc., basically building up a three-dimensional structure of the standard organization system of medical devices with horizontal (general standardization committee, working group, authorized organization) to the edge, vertical (subcommittees for standards) to the end, vertical (standardization committee directly under the working group) support.

(iii) Establishing technical reserves for epidemic prevention and control standards in the new phase

In 2023, China NMPA paid close attention to the prevention and control of monkeypox virus, and organized the project application for the national standard of Quality Evaluation Requirements for Monkeypox Virus Nucleic Acid Detection Kits to regulate the production and quality control of monkeypox virus nucleic acid detection kits. China NMPA organized and carried out the translation of five national standards, including Quality Evaluation Requirements for COVID-19 Nucleic Acid Detection Kits, Quality Evaluation Requirements for COVID-19 Antibody Detection Kits, Quality Evaluation Requirements for COVID-19 IgG Antibody Detection Kits, Quality Evaluation Requirements for COVID-19 Antigen Detection Kits, and Quality Evaluation Requirements for COVID-19 IgM Antibody Detection Kits.

(iv) Comprehensive completion of the assessment and evaluation of the dual coverage of the standardization committee

(v) Enterprise-led industry standard formulation and revision continues to gain momentum

China NMPA launched an initiative to encourage enterprises to take the lead in drafting industry standards for medical devices. In 2023, the Guidelines for Enterprises to Lead the Drafting of Recommended Industry Standards for Medical Devices (Trial) were issued. As a result, 22 enterprise-led standard formulation and revision tasks were issued, marking the initial establishment of an enterprise-led, standardization committee-guided work mode in the medical device industry.

(vi) Standardizing the promotion of standard review and implementation evaluation

In 2023, China NMPA further strengthened the requirements for standard review and accelerated the construction of the standard implementation evaluation system. China NMPA completed the review of 942 current medical device standards and put forward the conclusions of the review; organized and executed an evaluation of the implementation of 45 typical standards, culminating in a detailed report on the implementation evaluation.

(vii) Establishing a mechanism for updating standards with rapid linkage to international standards

For international standards that are deemed appropriate for adaptation to China's unique national circumstances, we will closely monitor their development, conduct thorough research, and undertake synchronized transformations, ideally within a two-year window following the publication of the international standards. In 2023, a total of 66 international standards were incorporated into national and industrial standards for medical devices, while 86 project plans for adapting international standards to China's national and industrial standards were approved and issued. As a result, the consistency level of international standards for medical devices exceeded 90%.

(viii) Accelerating the internationalization of medical device standards

In 2023, the international standard Aerosol bacterial retention test method for air-inlet filter on administration devices (standard No. ISO 24072:2023), which was developed by China, was officially released. Additionally, the international standard proposal Artificial intelligence enabled medical devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods (Project No. IEC 63524 ED1) was successfully established. Furthermore, six international standards were formulated and revised and the transformation of nine medical device standards into foreign languages has been progressing steadily. China's expertise in the field was recognized with the election of two Chinese experts as the Chairman of IEC SC 62B and the Vice-Chairman of IEC TC62. A total of 52 international standard meetings were organized, and 129 international standard votes were cast on behalf of China to participate in counterparts with the International Organization for Standardization. Moreover, 8 new experts registered with the International Organization for Standardization were added. The internationalization of medical device standards has been moving from integration to fusion.

(ix) Creating a positive social atmosphere for standardization

(x) Consistent standard service concepts