On September 4, 2017, the State Food and Drug Administration (hereinafter referred to as the “General Administration”) held a press conference to officially release the newly revised “Classification Catalog for Medical Devices” (hereinafter referred to as the New “Classification Catalog”). Effective from August 1, 2018.
Medical device classification management is an internationally accepted management model, and scientific and reasonable medical device classification is an important basis for the supervision of the entire process of medical device registration, production, operation and use.
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 the medical device industry and the continuous emergence of new technologies and new products, the medical device classification system has been unable to meet the needs of industrial development and regulatory work. The 2002 version of the “Medical Device Classification Catalog” (hereinafter referred to as the original “Classification Catalog”) The shortcomings of the industry have become more and more prominent: First, the original “Classification Catalog” is not detailed enough, and the overall framework and level setting cannot meet the current status of the industry and regulatory requirements. Second, the original “Catalogue” lacked key information such as product description and intended use, which affected the uniformity and standardization of registration approval. Third, the original “Category Catalog” was difficult to cover new products and new categories. Due to the lack of a dynamic adjustment mechanism, the content of the catalog could not be updated in time, and the product category division was not reasonable.
In order to implement the “Regulations on the Supervision and Administration of Medical Devices” revised and promulgated by the State Council and the “Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices”, the State Food and Drug Administration has comprehensively summarized and analyzed the medical devices issued over the years in accordance with the deployment of medical device classification management reforms. Device classification and definition files, sorting out the information of valid medical device registration products, and researching the management of similar foreign medical devices. The revision work was launched in July 2015, and the overall optimization and adjustment of the framework, structure and content of the “Classification Catalog” was carried out. Set up the Medical Device Classification Technical Committee and its professional group, systematically demonstrated the scientificity and rationality of the contents of the “Classification Catalog”, and revised the new “Classification Catalog”.
The new “Category Catalog” is divided into 22 sub-categories according to the characteristics of medical device technology and clinical use. The sub-categories are composed of first-level product categories, second-level product categories, product descriptions, intended uses, examples of product names, and management categories. When determining the product category, a comprehensive determination should be made based on the actual situation of the product, combined with the product description, intended use and product name examples in the new “Classification Catalog”. The main features of the new “Classification Catalog” are as follows: First, the structure is more scientific and more in line with clinical practice. Drawing lessons from the clinical use-oriented classification system in the United States, referring to the structure of the “Framework Catalog for Notified Bodies of the European Union”, the 43 sub-categories of the current “Classification Catalog” have been consolidated into 22 sub-categories, and 260 product categories have been refined and adjusted to 206 first-level product categories and 1157 second-level product categories form a three-level catalog hierarchy. Second, the coverage is wider, more instructive and operability. More than 2,000 new products have been added for expected uses and product descriptions, and the current “Classification Catalog” has been expanded to 6,609 examples of 1008 product names. The third is to rationally adjust product management categories, improve the adaptability of the industry status quo and the actual supervision, and provide a basis for optimizing the allocation of supervision resources. According to the degree of product risk and the actual supervision, the management category of 40 medical device products with a long time to market, high product maturity and controllable risks are reduced.
The framework and content of the new “Classification Catalog” have been greatly adjusted, which will have an impact on all aspects of medical device registration, production, operation, and use. In order to ensure a unified understanding of all parties, a smooth transition, and orderly implementation, the State Food and Drug Administration simultaneously issued and implemented the “Notice on the Implementation of the Newly Revised <Medical Device Classification Catalog>”, giving nearly a year of implementation transition time. To guide the regulatory authorities and related enterprises to implement. Regarding registration management, fully considering the status quo of the medical device industry, adopting a natural transition channel to implement the new “Classification Catalog”; for post-marketing supervision, production and operation supervision can adopt the new and old classification coding systems in parallel. The State Food and Drug Administration will organize all-round system training on the new “Classification Catalog” and guide local regulatory authorities and manufacturing companies to implement the new “Classification Catalog.”
2018 new medical device classification catalog Content source: China Food and Drug Administration, http://www.sda.gov.cn/WS01/CL0051/177088.html
Post time: Mar-02-2021