From the State Administration of Drug Administration, as of the end of 2018, there were 1618 medical device standards in China, including 219 national standards and 1399 industry standards. The consistency of China's medical device standards with international standards has reached more than 90%. The coverage and systematicity of the standard system have been continuously strengthened. The overall level of medical device standards is constantly improving.
The medical device standard is a technical specification that medical device development, production, operation, use, and supervision and management all follow, and an important technical support for medical device supervision and industrial development. The State Food and Drug Administration attaches great importance to the work of medical device standards, in accordance with the requirements of the "four most stringent", combined with the development of the medical device industry and the actual supervision work, continuously improve the medical device standard management system and continue to carry out medical device standards revision work The medical device standard system has been continuously improved, and the technical support capability of the medical device standard for supervision and industrial development has been continuously improved.
Based on the development and supervision of China's medical device industry, in April 2017, the original Food and Drug Administration revised and issued the "Administrative Measures for Medical Device Standards". The promulgation of this measure has played a positive role in guiding the management of medical device standards in China, standardizing and revising standards, promoting the implementation of standards, and improving the quality of medical devices. In order to implement the "Administrative Measures for Medical Device Standards", the original Food and Drug Administration has issued documents such as "Management Standards for the Revision of Medical Device Standards" and "Working Rules for the Approval and Release of Medical Device Standards" and other documents to further standardize the medical device standard work procedures. Strengthened the management of the refined process of standards, and laid a solid institutional foundation for improving the quality of medical device standards.
During the "Twelfth Five-Year" and "Thirteenth Five-Year" period, the drug regulatory department continued to implement the medical device standard upgrade plan, and organized and revised about 100 medical device standards every year. For major basic standards, general standards, high-risk product standards, strategies Priority is given to the establishment of standards in related fields of emerging industries. In 2018, 99 items of medical device industry standards were revised and selected, and 104 items of medical device industry standards were reviewed and issued.
The drug regulatory department has also actively promoted the preparation of strategic emerging medical device related standard committees. On the basis of the existing 24 medical device standardization (sub) technical committees, combined with the actual development of the medical device industry, in 2018, it is actively preparing to build a national surgical implant He orthopedic device standardization technical committee active implant sub-technical committee, national medical device biological evaluation standardization technical committee nano medical device biological evaluation sub-technical committee and medical electroacoustic equipment, medical additive manufacturing technology, artificial intelligence
Three medical device standardization technologies are under the jurisdiction of medical devices to further improve the construction of a medical device standard organization system.
In order to enhance the international voice of China's medical device standards, the drug regulatory department deeply participates in and promotes the relevant activities of the International Medical Device Regulators Forum (IMDRF) Standards Working Group. In 2018, at the 13th IMDRF Management Committee meeting, the new work item “Update IMDRF Member Recognized International Standards List” proposed by our country was unanimously approved and passed. breakthrough. For the first time, he led the formulation of international standards for high-performance medical devices. At the 2017 annual meeting of the International Committee for Standardization of Surgical Implants (ISO / TC150), the proposal for an international standard for "cardiovascular implant heart occluder" was approved and was the first in China. The conversion of three medical device industry standards into ISO international standards has important groundbreaking significance for promoting the internationalization of China's medical device standards. It has effectively enhanced the international voice of China's medical device field and promoted the integration of China's standards with international standards.
(Source: China Quality News)