Now we have a new catalogue of medical devices!

As we all know, the classification system of medical devices in China is under the guidance of classification rules. The classification rules coexist with the classification catalogue, and the classification catalogue takes precedence. On July 14, 2015, the State Food and Drug Administration issued the classification rules of medical devices, which was formally implemented from January 1, 2016. If the revision of medical equipment classification catalogue is carried out smoothly, the new version of medical device classification catalogue is expected to be released this year!
 
The revision started with high profile
 
From February 24 to 25 this year, the Institute of medical device standards management of 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 classified catalogue of medical devices (the first batch).
 
The meeting was attended by not only leaders from the medical device registration and Management Department of the State Administration of China, but also experts from clinical medical institutions, technical evaluation center of General Administration of medical devices, relevant provincial regulatory agencies, medical device testing institutions, medical device evaluation institutions and some enterprise representatives. From the perspective of the strong lineup. It shows that the new medical equipment classification catalogue has been launched with high profile, so it may be available this year.
 
Progress of revision
 
It is particularly noteworthy that the Institute of mechanical standards of the Chinese Academy of inspection has undertaken the organizational research on the revision of the classification catalogue of medical devices. At the meeting, relevant persons in charge disclosed the specific progress:
 
First, the working group on Revision of medical equipment classification catalogue has been set up, the personnel and office conditions have been equipped, and the revision work is on the way;
 
Second, the original 43 medical device subdirectories have been adjusted to the current 22 subdirectories, and the revision of 11 subdirectories has been preliminarily completed, and the first draft of some relevant subdirectories has been completed in advance, and the revision progress is much faster than expected;
 
Third, the names of primary and secondary directories have been preliminarily determined, and the sub directory framework is more forward-looking and scientific;
 
Fourthly, the dynamic database for the revision of the catalogue has been established, and the registration data of medical devices involved in the revision of classified catalogue have been sorted out and extracted.
 
What is the impact on enterprises?
As we all know, medical device classification is the basis and source of medical device management. The previous new edition of "medical device classification rules" has been implemented, but because of its macro and abstract content, it is still difficult to directly apply it to classify new products. Therefore, the release of the new version of "medical device classification catalog" will be a timely rain, so that many enterprises troubled by classification problems can be extricated.
 
The new medical equipment classification catalogue will clarify the ownership of some products, and directly guide the R & D registration and production of enterprises. The description, intended use and product name examples of each subhead in the new medical equipment classification catalogue will further guide enterprises to correctly classify products, which is a more scientific progress than the old classification catalogue.
 
The revision of classified catalogue is the basic work of the reform of the review and approval mechanism of medical devices, and it is also a major event in the supervision of medical devices. The progress made in the revision of the classified catalogue of medical devices plays a guiding role in the reform of the review and approval mechanism of medical devices. There is no doubt that this will be of great help to the supervision of medical devices in the future!