As is known to all, the classification of medical devices in China implements the classification catalog system under the guidance of classification rules. The classification rules and classification catalog coexist, and the classification catalog takes priority. On July 14th, 2015, the State Food and Drug Administration issued the classification rules for medical devices, which was officially implemented on January 1st, 2016. If the revision of the medical device classification catalog goes smoothly, the new version of the medical device classification catalog is expected to be released this year!

High profile start of revision work

From February 24 to 25 this year, the Institute of medical device standards management of the China Academy of food and drug control (hereinafter referred to as the Institute of medical device standards) organized a preliminary meeting in Beijing to solicit opinions on the revision of the medical device classification catalog (the first batch).

The meeting was attended by not only the leaders of the Department of medical device registration and management of the State Administration, but also relevant experts and some enterprise representatives from clinical medical institutions, the medical device technology evaluation center of the State Administration, relevant provincial and bureau regulatory agencies, medical device testing institutions, and medical device evaluation institutions. Judging from the participants, the lineup is strong. It indicates that the new medical equipment classification catalog has been launched with a high profile, which can be seen that it may be available this year.

Progress of revision work

It is particularly noteworthy that the Institute of mechanical standards of the Chinese Academy of inspection has undertaken the organizational research work of the revision of the classification catalog of medical devices. At the meeting, the relevant person in charge disclosed the specific progress:

First, the working group for the revision of the medical equipment classification catalog has been established, the personnel and office conditions have been equipped, and the revision work is on the way;

Second, the original 43 sub directories of medical devices have been adjusted to the current 22 sub directories, and the revision of 11 sub directories has been preliminarily completed. The first draft of relevant sub directories has been completed ahead of schedule, and the revision progress is much faster than expected;

Third, the names of the primary directory and secondary directory have been preliminarily determined, and the sub directory framework is more forward-looking and scientific;

Fourth, the dynamic database required for catalog revision has been established, and the medical device registration data information involved in catalog revision has been sorted out and extracted.

How does it affect the enterprise?

As we all know, medical device classification is the basis and source of medical device management. The previous version of the medical device classification rules has been issued and implemented, but because it is relatively macro and abstract, it is still difficult to directly apply it to classify new products. Therefore, the release of the new version of the medical device classification catalog will be a timely rain, so that many enterprises troubled by classification problems will be relieved.

The new medical equipment classification catalog will clarify the ownership of some products and directly guide the R&D, registration and production of enterprises. The product description, intended use, product name examples and other contents of each sub item in the new version of the medical equipment 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 classified catalogue is the basic work of the reform of the review and approval mechanism of medical devices, and is a major event in the supervision of medical devices. The progress made in the revision of the medical device classification catalog will play a guiding role in the reform of the medical device review and approval mechanism. There is no doubt that this will be of great help to the future supervision of medical devices in China!