The Institute of Medical Apparatus Standards Management of China Food and Drug Inspection Institute (hereinafter referred to as the Institute of Medical Apparatus Standards) organized a work committal hearing on the revision of the medical apparatus classification catalog in Beijing. It was mentioned at the meeting: The State Food and Drug Administration issued the "Classification Rules of Medical Apparatus", which came into effect on January 1, 2016. If the revision of the medical apparatus classification catalog goes smoothly, the new version of the "Classification Catalog of Medical Apparatus" is expected to be released this year! In addition, relevant people also revealed the specific progress: 1. The working group on the revision of the medical apparatus classification catalog has been established, the personnel and office conditions have been equipped, and the revision work is on the way. Adjusting the original 43 medical apparatus subdirectories to the current 22 subdirectories has preliminarily completed the revision of 11 subdirectories, and the first draft of the relevant subdirectories has been completed in advance, and the revision progress is much faster than expected. 

3. The first-level and second-level catalog names have been initially determined, and the subdirectory framework is more forward-looking and scientific.

4. The dynamic database required for the revision of the catalogue has been established, and the registration data information of medical apparatus involved in the revision of the catalogue has been sorted and extracted. So what is the impact on medical apparatus enterprises? As we all know, the classification of medical apparatus in our country implements the classification catalogue system under the guidance of the classification rules. The classification rules and the classification catalogue coexist, and the classification catalogue gives priority to the medical apparatus classification system. The classification of medical apparatus is the basis and source of medical apparatus management. The previous new version of the "Classification Rules of Medical Apparatus" has been introduced and implemented, but because it is relatively macroscopic and abstract in content, it is still difficult to directly apply it to classify new products. The release of the new edition of the "Classification Catalogue of Medical Apparatus" will be a timely rain, relieving many companies that are troubled by classification problems. The new edition of the classification catalogue of medical apparatus will clarify the attribution of some products and directly guide the R & D registration and production of enterprises. The product descriptions, intended uses, and product name examples of each sub-category in the new edition of the classification catalogue of medical apparatus will further guide enterprises to correctly classify products, so that enterprises can layout the market in the future.