China Medical Device Standards Management Annual Report 2024

On February 10, 2025, the National Medical Products Administration (NMPA) released the "Annual Report on the Administration of Medical Device Standards in China (2024)", detailing significant advancements in the development, revision, and implementation of over 2,000 medical device standards. The updated standards system introduces refined classifications, new technical units, and expanded international participation. These developments have direct implications for international manufacturers, who should align their product design, testing, and registration strategies with evolving Chinese requirements to ensure continued market access

Latest Progress in China's Medical Device Standards System

1. Dual Improvement in Standard Quantity and Quality: NMPA's report stated that in 2024, China's medical device standardization work achieved "remarkable progress", with the number of valid medical device standards exceeding 2,000.

Steady Growth in Standard Quantity: As of the end of 2024, there were 2,023 valid medical device standards, including 296 national standards and 1,727 industry standards.

More Refined Standard System Structure: The valid standards include 349 foundational standards (17.2%), 54 management standards (2.7%), 488 method standards (24.1%), and 1,132 product standards (56.0%). In 2024, newly released standards included 40 foundational, 4 management, 17 method, and 78 product standards, accounting for 28.8%, 2.9%, 12.2%, and 56.1%, respectively.

2. Accelerated Standard Development and Revision: In 2024, the Standardization Administration of China and the NMPA issued 49 and 90 medical device standards, respectively, including both new and revised standards. The NMPA report stated that, "These standards provide a clear basis for medical device production and regulation while supporting technological innovation and high-quality development."

National Standard Releases: Of the 49 national standards, 28 (57.1%) were newly developed, and 21 (42.9%) were revisions. These included 7 mandatory standards (14.3%), 40 recommended standards (81.6%), and 2 guiding technical documents (4.1%).

Industry Standard Releases: Of the 90 industry standards, 36 (40.0%) were newly developed, and 54 (60.0%) were revisions. These included 15 mandatory standards (16.7%) and 75 recommended standards (83.3%).

3. Continuous Optimization of Standardization Technical Organizations: In 2024, the NMPA approved the establishment of a medical device packaging standardization technical unit, enhancing the technical organizational structure for medical device standardization. Currently, there are 39 medical device standard technical organizations covering all medical device fields, The NMPA report stated that this "improving the scientific and professional nature of standard development and offering more opportunities for international manufacturers."

International Standardization

In 2024, China actively participated in international standardization efforts, submitting six proposals for new international standard projects. Six international standards, including "Artificial Intelligence in Medical Devices - Lung Image Auxiliary Analysis Software - Algorithm Performance Testing Methods," were advanced, and China-led ISO 7151:2024 "Surgical Instruments - General Requirements and Test Methods for Non-Cutting Hinged Instruments" was approved and released.

Implications and Strategies for Overseas Manufacturers

1. Adjusting Registration Strategies: With the continuous improvement of China's medical device standards system, international manufacturers need to pay more attention to adjusting their registration strategies. Manufacturers must ensure their products meet the latest mandatory national and industry standards, which may involve adjustments to product design, manufacturing processes, and quality control. They also need to closely monitor standard development and revision to avoid registration delays due to changes in standards.

2. Adjusting Registration Time Cycles: The ongoing updates and refinements to standards may revise medical device registration times shorter or longer. Because standards are increasingly clear and harmonized with international standards, this can support international manufacturers type testing and dossier preparation times. But there can also be additional requirements set out in the revised standards that can lengthen some timelines. International manufacturers should plan ahead and continually review the latest standards that apply to their device, ensuring that any standards updates are managed appropriately.

3. Enhanced Testing Requirements: The new standards system imposes stricter testing requirements for medical devices. International manufacturers must ensure their products pass rigorous quality and performance tests before entering the Chinese market. This includes safety, effectiveness, and compatibility with human tissues, as well as environmental adaptability. Collaboration with professional testing institutions is necessary to meet China's standard requirements.

4. Relationship Between Standard Changes and Registration Renewal: When renewing medical device registration certificates, overseas manufacturers must be mindful of standard change timelines and requirements to ensure product compliance with the latest standards. Key points include:

Process for Standard Changes and Registration Renewal: If new mandatory standards are released during the validity of a medical device registration certificate and registered products need to meet these standards, registrants must complete change registration before applying for renewal. This means submitting a change registration application and obtaining approval before proceeding with renewal.

Importance of Timely Actions: Companies must submit renewal applications six months before the registration certificate expires. Complex or time-consuming change registration processes may affect the timeliness of renewal. Therefore, companies need to plan their time reasonably to complete all necessary change and renewal processes within the specified timeframe.

Exceptions: If new mandatory standards only adjust the year without substantive content changes, companies can apply for a standard number update without full change registration. However, if the standard content changes substantially, product compliance must be re-verified.

Mandatory Nature of Regulations: According to the "Administrative Measures for the Registration and Filing of Medical Devices," if new mandatory standards are implemented and registered products fail to meet these requirements, renewal registration will be denied. This underscores the importance of companies updating standards promptly.

By implementing the above measures, overseas manufacturers can better manage the relationship between standard changes and registration renewal, ensuring product compliance and continuity in the Chinese market.

Further Information

To read the original NMPA 2024 Medical Device Standard Management Annual Report, please click here.

If you are a medical device manufacturer with questions about how China’s 2024 standard updates affect your product registration or compliance process, please contact Cisema.