One of the steps in the approval process for medical devices in China is ensuring compliance with Chinese electrical safety standards and passing local tests. If not thoroughly understood, these requirements can pose significant challenges and may consume considerable time and effort. Although the local partner in China is responsible for overseeing the applicable standards and coordinating with test laboratories, regulatory affairs managers need to have a solid understanding of Chinese standardization and the ability to access relevant information.
GB & YY: What Do They Stand For?
In China, international standards are adopted as national standards and may be supplemented with additional requirements specific to the country. There are two types of standards in China: national standards, marked with a GB before the standard number to indicate the publishing entity, the Chinese Standardization Agency (SAC). The NMPA publishes industry standards, which can be identified by the letters YY before the standard number. Recommended but not mandatory standards are indicated by the suffix /T.
Abbreviation | Details | Published by |
---|---|---|
GB | National standards | Standardization Administration of China (SAC) |
YY | Industry standards for medical devices and IVD | National Medicinal Products Administration (NMPA) |
Staying Informed on Standard Status and Updates
The SAC releases monthly reports on national and industry standards. Although these reports cover various sectors, identifying the relevant industry standards for medical devices is straightforward: search for "YY" to find standards issued by the NMPA.
Source: Link
The national standards catalogue maintained by the Standardization Administration of China (SAC) provides information on the current status of standards and about ongoing revisions. The Centre of Medical Device Evaluation (CMDE) also regularly publishes a list of mandatory national standards for medical devices, listed by product category. The most recent version of this list was published in June 2024.
Standards in Focus: Medical Electrical Equipment
The following outlines the process for verifying the status of Chinese standards applicable to medical electrical equipment. The National Standards Catalogue allows for free-text search, but only in Chinese. While English translations are included for national GB standards, they are not provided for YY industry standards. The process is most straightforward when the standard number is already known. For instance, the general requirements for medical electrical equipment are governed by GB 9706.1 for medical devices.
Source: Link
Source: Link
The related industry standards (YY) can be found at the bottom of the page:
Source: Link
In addition to translation tools, the naming conventions of the standards help you identify whether a standard is generic, collateral, or specific to a particular product. The table below provides an overview using the example of medical electrical equipment:
Generic standard | Collateral standard | Product specific standard | |
---|---|---|---|
Naming convention | GB NNNN.N-YYYY | GB NNNN.10X-YYYY | GB NNNN.20X-YYYY |
National standard | GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance |
GB 9706.103-2020 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment |
GB 9706.208-2021 Medical electrical equipment –Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
Industry standard | YY 9706.102-2021 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Parallel Standards: Electromagnetic Compatibility Requirements and Tests |
YY 9706.268-2022 Medical Electrical Equipment Part 2-68: Specific requirements for the basic safety and essential performance of X-ray image-guided radiotherapy devices for electron accelerators, light ion beam therapy devices, and radionuclide beam therapy devices |
Conclusion and the CMDE list of mandatory standards
With this information, you can consult the CMDE List of Mandatory Standards for Medical Devices, which is organized according to the Chinese product classification catalogue. This allows for the identification of the mandatory standards applicable to a device. Once identified, these standards should be incorporated into the list of applicable standards (LAST) and regularly monitored for updates or changes.
The following links are essential for conducting standards research in China and staying updated:
- SAC National Standards Catalogue
https://std.samr.gov.cn/ - SAC monthly reports of the National Standards Catalogue
https://std.sacinfo.org.cn/ - NMPA Industry Standards Announcements
https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxhybzhgg/index.html - CMDE List of Mandatory Standards for Medical Devices (10.11.2023)
https://www.cmde.org.cn/xwdt/zxyw/20221118133123194.html
Annika Lörtscher
Senior Regulatory Affairs and Knowledge Manager