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| 《Catalogue of medical devices》The name of the product was expanded to 6609 |
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| Author：中国铭铉 企划部 Release Time：2017-9-6 15:51:22 Number Browse：829 |
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On September 4, the state administration of food and drug administration held a press conference to release the newly revised catalogue of medical devices (hereinafter referred to as the new classification catalogue). The new catalogue will be implemented from August 1, 2018. National food, director-general of the department of drug safety administration of medical device registration of Kings male said, the new increase more than 2000 products in the catalogue of classification, intended use and the product description, will present the classification catalogue 1008 name for expanded to 6609; Coverage will be broader, more instructional and operational.
King xiong said that the framework and content of the new catalogue will be adjusted greatly, which will affect the registration, production, operation and use of medical devices. In order to ensure the unified understanding, a smooth transition and orderly implementation of the national food administration of drug safety synchronous printing on the implementation of the medical devices category > announcement of relevant matters, for nearly a year of transition time, to guide the supervision departments and relevant enterprises to carry out.
It is known that medical device classification management is a common international management model, scientific and rational classification of medical devices is a medical device registration, production, management and use of the important foundation of the whole process of supervision. New the catalog of classification according to professional characteristics and clinical use of medical equipment technology is divided into 22 subdirectory, subdirectories by primary product categories, secondary product category, product description, intended use, commodity management category and examples.
King male, new the catalog of classification of clinical use of oriented in us classification system, refer to the catalog of the eu notified body with framework structure, will present the classification catalogue of 43 subdirectory streamlined for 22 subdirectory, adjust refine 260 product categories for 206 primary product categories and 1157 secondary products category, form three directories hierarchy, will be more scientific, more relevant to clinical practice. In addition, it will improve the current situation of the industry and the actual adaptability of supervision, and provide a basis for optimizing the allocation of regulatory resources.
At present, there are about 77,000 medical device registration certificates and more than 37,000 medical device registration certificates in China. With the rapid development of medical equipment industry, new technologies, new products constantly emerging, medical device classification system has been difficult to adapt to the needs of industrial development and the supervisory work, 2002 version of the catalog of medical device classification of the growing lack of.
The king also said that, with regard to registration management, the current situation of medical device industry should be fully taken into account, and the new classification catalogue should be implemented in a natural and transitional way. For the post-ipo supervision, the production and operation supervision adopt the old and new two kinds of classification coding system in parallel.
It is reported that the state administration of food and drug administration will conduct all-round systematic training of the new classification catalogue and guide the local regulators and related enterprises to implement the new classification catalogue.
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