As we all know, the classification of medical apparatus in our country implements the classification catalog system under the guidance of the classification rules. The classification rules and the classification catalog coexist, and the classification catalog gives priority to the classification system of medical apparatus. On July 14, 2015, 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 well, the new version of the "Classification Catalog of Medical Apparatus" is expected to be released this year!

Revision work starts in high profile

From February 24th to 25th this year, the Institute of Medical Apparatus Standards Management of China Food and Drug Inspection Institute (hereinafter referred to as the Institute of Machinery Standards) organized a work committal hearing on the revision of the medical apparatus classification catalog (the first batch) in Beijing.

Attending the meeting were not only the leaders of the medical apparatus registration management department of the State Administration, but also relevant experts and some enterprise representatives from clinical medical institutions, the medical apparatus technical evaluation center of the General Administration, relevant provincial regulatory agencies, medical apparatus testing institutions, medical apparatus evaluation institutions. From the participants, the lineup is strong. It shows that the new version of the medical apparatus classification catalog has been launched on a high-profile, which can be seen that it may be launched this year.

Revision work progress

It is particularly noteworthy that the Institute of Mechanical Labels of the Central Inspection Institute has undertaken the organizational research work of revising the classification catalogue of medical apparatus. The relevant person in charge at the meeting revealed the specific progress:

First, the working group on the revision of the medical device classification catalogue has been established, and the personnel and office conditions have been equipped. The revision work is already on the way.

The second is to adjust the original 43 subdirectories of medical apparatus to the current 22 subdirectories, and the revision of 11 subdirectories has been initially completed. The first draft of the relevant subdirectories has been completed in advance, and the revision progress is much faster than expected;

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

Fourth, 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 out and extracted.

What is the impact on the business?

As we all know, medical apparatus classification is the foundation and source of medical apparatus management. The previous version of the "Medical Apparatus Classification Rules" 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. Therefore, the release of the new version of the "Medical Apparatus Classification Catalog" will be a timely rain, relieving many enterprises that are troubled by classification problems.

The new version 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 version of the medical device classification catalog will further guide enterprises to correctly classify products, which is a more scientific progress than the old version of the classification catalog.

The revision of the classification catalogue is the basic work of the reform of the review and approval mechanism of medical apparatus, and it is a major event in the supervision of medical apparatus. The progress made in the revision of the classification catalogue of medical apparatus will play a guiding role in the reform of the review and approval mechanism of medical apparatus. There is no doubt that this will be of great help to the supervision of medical apparatus in our country in the future!