The Institute of Medical Apparatus Standards Management of China Food and Drug Inspection Institute (hereinafter referred to as the Institute of Mechanical Standards) organized a work committal hearing on the revision of the medical apparatus classification catalog (the first batch) in Beijing.

It was mentioned at the meeting that the State Food and Drug Administration issued the "Classification Rules for Medical Apparatus", which came into effect on January 1, 2016. If the revision of the classification of medical devices goes well, the new version of the "Classification of Medical Apparatus" is expected to be released this year!

In addition, relevant sources also revealed specific progress:

1. The working group on the revision of the medical device classification catalogue has been established, the personnel and office conditions have been equipped, and the revision work is already 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 directory revision has been established, and the medical apparatus registration data information involved in the classification directory revision has been sorted and extracted.

So what is the impact on medical apparatus companies?

As we all know, the classification of medical apparatus in our country implements the classification catalog system under the guidance of classification rules, and the classification rules and the classification catalog coexist.

The classification of medical apparatus is the basis and source of medical apparatus management. The new version of "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 medical device classification catalog will clarify the attribution of some products and directly guide the R & D registration and production of enterprises. The content of each sub-category product description, intended use, product name examples, etc. in the new edition of the medical device classification catalog will further guide enterprises to correctly classify products, so that enterprises can layout the market in the future.