the classification of medical devices will realize dynamic s
with the rapid development of the medical device industry, the 2002 edition of the original catalogue has been unable to meet the new needs of the development of industry and supervision. the new "directory" will be released after the change of medical devices according to the risk analysis, scientific judgment on the part of the dynamic adjustment of product management category, and promptly announced, the realization of china's medical device classification accuracy and scientific
the newly revised catalogue of medical devices will be implemented in august 1, 2018 by the state food and drug administration.
the classified management of medical instruments based on the degree of risk is an important basis for the whole process of medical equipment registration, production, operation and use." the state food and drug administration device registration secretary wang zhexiong introduced the classification management of medical devices is the international management mode, in accordance with china's relevant laws and regulations, promulgated in china in 2002 2002 edition of the directory, the implementation of classification item classification rules under the guidance of the record, to a certain role in promoting the medical supervision and the industrial development, but with the rapid development of medical equipment industry, the rapid growth of high-end products, and the higher complexity of the products continue to emerge, the application of new technology, to guide the clinical application of combination, the emergence of a large number of products, the 2002 version of the original "directory" has been unable to adapt to the new needs of industrial development and supervision.
at present, the medical device industry has become an important pillar industry in the world economy. data show that the global medical device market total sales from 2001 to 187 billion u. s.dollars, has increased to $501 billion 800 million in 2014, an average annual compound growth rate of 8.82%. china medical equipment industry association data also show that in 2016 the national medical equipment output value of more than 550 billion yuan, an average annual compound growth of about 20%, industry growth continued to maintain two figures. in this regard, li bo dean of the china institute for food and drug control, chinese medical equipment industry has developed into a complete range of products, innovation ability, the market continued strong demand for the sunrise industry.
classification is the prerequisite and basis for the implementation of classified management of medical devices, and plays an important role. for the medical equipment regulatory chain, it can be described as "one move and move the whole body"; for industrial development and product development, it also has leverage.
li bo believes that the original 2002 edition of the "classified directory" set up 43 sub directories, due to the division of subdirectories from many angles, a large number of directories, it is easy because of the lack of a unified division principle, resulting in cross overlap between directories. the "new" directory "mainly in the technical field as the main line, pay more attention to the medical device function and clinical use of the product attribution, streamlined consists of 43 sub directory integration of the original" classification directory "for the 22 sub directories, product category refinement also adjusted for the 206 level 1157 level two product categories and product categories three, forming a directory hierarchy, and cited the example of 6609 name, is conducive to the unity of all knowledge and execution." li bo says.
it is worth noting that, in order to ensure the smooth transition and orderly implementation of the new catalogue, the state food and drug administration issued the circular on the implementation of relevant matters at the same time. in this regard, wang zhexiong explained that, in the implementation of the new classification catalogue, the parties concerned will be given a transitional period of nearly a year, in order to deepen the understanding of various aspects of the new classification directory and understanding. in view of the registration management, taking full account of the current situation of the medical device industry, the new classification catalogue will be implemented in the form of a natural transition, and the production and operation supervision can be carried out in parallel with the two new classification coding systems.
after the publication of the new catalogue, we will further increase the construction and management of the medical equipment classification information system." wang zhexiong said, in the future production, operation and use of the process, the food and drug administration will be based on the change of medical risk to analyze the scientific judgment on the part of the dynamic adjustment of product management category, and promptly announced, the realization of china's medical device classification accuracy and scientific.