World Standards Day | China's medical device standards have over 90% international consistency

October 14th each year is World Standards Day, also the anniversary of the founding of the International Organization for Standardization (ISO). On October 14, 1946, representatives from 25 countries gathered in London to create a new international organization, ISO, "to promote international coordination and unification of industrial standards" (ISO officially began operations in 1947).

World Standards Day

We live in a world of standards; life is inseparable from standards.

The International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU) have set the theme for World Standards Day 2019 as:

Video Standards Create a Global Stage

(Video standards create a global stage)

2019 World Standards Day Publicity Poster (Chinese Version)

In fact, not only in the video field, but any technology that changes our world is supported by standards. Therefore, it can be said that standards have changed the world, changed people's lifestyles, and made life more efficient and better!

Medical devices are related to people's health and safety. During the "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" periods, China's medical device standardization work has made significant progress -

Do you understand China's medical device standard system?

Medical device standards are technical specifications jointly followed in the research, production, operation, use, and supervision and management of medical devices. They are an important technical support for medical device supervision and industrial development. The State Drug Administration attaches great importance to medical device standards, following the requirements of "the four strictest," combining the actual situation of medical device industry development and supervision work, constantly improving the medical device standard management system, and continuously carrying out the formulation and revision of medical device standards. China's medical device standard system is constantly improving, and the technical support ability of medical device standards for supervision and industrial development is continuously improving.

1. Strengthening the Construction of Medical Device Standard System

In order to implement the major decision-making arrangements of the State Council's deepening standardization reform, in accordance with the "Standardization Law of the People's Republic of China," and based on the actual situation of China's medical device industry development and supervision work, in April 2017, the former State Food and Drug Administration revised and issued the "Medical Device Standard Management Measures." The issuance of this measure has played a positive role in guiding the management of China's medical device standards, standardizing the formulation and revision of standards, promoting the implementation of standards, and improving the quality of medical devices. In order to implement the "Medical Device Standard Management Measures," the former State Food and Drug Administration successively issued documents such as "Management Specifications for the Formulation and Revision of Medical Device Standards" and "Detailed Rules for the Approval and Issuance of Medical Device Standards," further standardizing the procedures for medical device standard work, strengthening the refined process management of standards, and laying a solid institutional foundation for improving the quality of medical device standards.

2. Accelerating the Formulation and Revision of Medical Device Standards

Continuously implementing the medical device standard improvement plan, during the "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" periods, about 100 medical device standards were formulated and revised each year, giving priority to major basic standards, general standards, high-risk product standards, and standards related to strategic emerging industries. In 2018, 99 medical device industry standard formulation and revision projects were selected and determined, and 104 medical device industry standards were reviewed and released. By the end of 2018, China had a total of 1618 medical device standards, including 219 national standards and 1399 industry standards. The consistency rate between China's medical device standards and international standards has reached more than 90%, the coverage and systematic nature of the standard system have been continuously strengthened, and the overall level of medical device standards has been continuously improved. Increasing the publicity of standards, establishing a public information platform for medical device standards, and achieving 100% publicity of the text of mandatory medical device industry standards and the catalog information of recommended medical device industry standards.

3. Improving the Medical Device Standard Committee System and Management

Actively promoting the establishment of strategic emerging medical device-related standard committees, based on the existing 24 medical device standardization (sub) technical committees, combined with the actual development of the medical device industry, in 2018, actively preparing for the establishment of the National Technical Committee for Standardization of External Surgical Implants and Orthopedic Devices, the Active Implantable Devices Sub-technical Committee, the National Technical Committee for Standardization of Biological Evaluation of Medical Devices, the Nano Medical Device Biological Evaluation Sub-technical Committee, and the three medical device standardization technical歸口 units of medical electroacoustic equipment, medical additive manufacturing technology, and artificial intelligence medical devices, further improving the construction of the medical device standard organization system.

4. Enhancing China's International Voice in Medical Device Standards

Deeply participating in and promoting the relevant activities of the International Medical Device Regulators Forum (IMDRF) standard working group, in 2018, at the 13th IMDRF Management Committee meeting, China's proposed new work item of "updating the IMDRF member-recognized international standard list" was unanimously approved, achieving a historical breakthrough for China from participating in to leading the formulation of international standard recognition rules for medical devices. For the first time, China led the development of international standards for high-performance medical devices. At the 2017 International Surgical Implant Standardization Committee (ISO/TC150) annual meeting, the international standard proposal for "Cardiovascular Implants Heart Occluders" was approved, which is China's first medical device industry standard to be transformed into an ISO international standard. This has important pioneering significance for promoting the internationalization process of China's medical device standards, effectively enhancing China's international voice in the field of medical devices, and promoting the alignment of China's standards with international standards.