Medical device standard is a common technical standard for medical device research, production, operation, use and supervision and management. It is an important technical support for medical device supervision and industrial development.State food and drug administration attaches great importance to the standard work of medical equipment, according to the requirements of "the four most strict", combining the reality of medical equipment industry development and regulatory work, constantly improve the system of medical instrument standard management system, continued to carry out the standard system revision work of medical equipment, continuously improve the medical devices standards system in China, the development of medical instrument standard of regulation and industry technical support ability to continue to ascend.
First, strengthen the construction of medical device standard system
To implement the major decision deployment deepening the reform of standardization under the state council, on the basis of the standardization law of the People's Republic of China, based on the development of China's medical equipment industry and regulatory work reality, in April 2017, the original issued by the food and drug supervision bureau revised the measures for the administration of medical devices standards, introduced the way to guide the national standards of medical equipment management, standard system revision, promote standard implementation, such as improving the quality of medical equipment has played a positive role.For the implementation of the "measures for the management of medical equipment standard", the food and drug supervision administration has issued by the medical devices standards work management and revising rules and the examination and approval of the medical devices standards published work detailed rules "and other documents, and further standardize the medical equipment standard work procedures, strengthening the management of the standard process of refinement and for improving the quality of medical devices standards system laid a solid foundation.
Accelerate the revision of medical device standards
We will continue to implement the plan to upgrade standards for medical devices. During the 12th Five-Year Plan period and the 13th Five-Year Plan period, we will organize the formulation and revision of about 100 standards for medical devices every year, and give priority to the approval of standards for major basic standards, universal standards, high-risk products, and standards in areas related to strategic emerging industries.In 2018, 99 medical device industry standards were selected and revised, and 104 medical device industry standards were reviewed and released. By the end of 2018, China had 1,618 medical device standards, including 219 national standards and 1,399 industrial standards.The consistency between China's medical device standards and international standards has reached over 90%. The coverage and systematicness of the standard system have been continuously enhanced, and the overall level of medical device standards has been constantly improved.We will strengthen the disclosure of standards, establish a platform for the disclosure of medical device standards, and achieve 100% disclosure of mandatory medical device industry standard text and recommended medical device industry standard catalog information.
3. Improve the system and management of medical device Standards Committee
Actively promote strategic emerging medical equipment related standard council planning, the existing 24 medical apparatus and instruments, on the basis of standardization technical committee (points), according to the development of medical equipment industry, actively planning the national 2018 surgical implants and orthopedic devices standardization technical committee active implants technical committee, the national biological evaluation of medical devices standardization technical committee of nano biological evaluation of medical devices technical committee and medical electronic equipment, medical materials manufacturing technology, artificial intelligence medical equipment standardization technology under centralized medical device of 3 units, further improve the medical devices standards organization system construction.
Fourth, enhance the international discourse power of medical device standards
Depth of participation and promote international medical device regulatory BBS (IMDRF) working group activities, in 2018, in IMDRF 13th management committee meeting, our country put forward the "update IMDRF members recognized international standard listing" project was agreed to by the new work, implements our country from participating in the leading international standard recognition rules of medical equipment a historic breakthrough.Leading to develop high performance the international standard of medical equipment, for the first time at the 2017 international surgical implants committee for standardization (ISO/TC150) annual meeting, the cardiovascular implants heart closure projects are proposed by the international standard, is China's first standard for medical devices industry into the ISO international standards, to promote our country medical instrument standard internationalization of pioneering significance, strongly promoted international discourse in the field of medical apparatus and instruments in China, promoted the standards in line with international standards in our country.