On September 4, the State Food and Drug Administration (hereinafter referred to as the "General Administration") held a press conference to officially release the newly revised "Classification Catalogue of Medical Devices" (hereinafter referred to as the "New Classification Catalogue"). It will be implemented on 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 are becoming increasingly prominent:
First, the original "Catalogue" was not detailed enough, and the overall framework and level setting could not meet the industry status and regulatory requirements. Second, the original "Classification Catalog" lacked key information such as product description and intended use, which affected the uniformity and standardization of registration approval. The third is that the original "Classification Catalog" is difficult to cover new products and new categories. Due to the lack of a dynamic adjustment mechanism, the content of the catalog cannot be updated in time, and the classification of product categories is not reasonable.
The new "Classification Catalog" is divided into 22 sub-categories according to the characteristics of medical device technology and clinical use. The sub-categories are composed of primary product categories, secondary product categories, product descriptions, intended uses, examples of product names, and management categories. When determining the product category, it should be based on the actual situation of the product, combined with the product description, intended use and product name examples in the new "Classification Catalog" for comprehensive determination.
The main features of the new "Catalogue" are:
First, the structure is more scientific and more in line with clinical reality. Drawing lessons from the clinical use-oriented classification system in the United States and 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 and streamlined into 22 sub-categories, and 260 product categories have been refined and adjusted to 206 There are three first-level product categories and 1,157 second-level product categories, forming a three-level catalog hierarchy.
The second is that the coverage is wider, more instructive and operability. The expected use and product description of more than 2,000 products have been added, and the current 1008 product name examples in the "Classification Catalog" have been expanded to 6,609.
The third is to rationally adjust product management categories, improve the adaptability of the industry's current situation 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 that have a long time to market, high product maturity and controllable risks are reduced.
