The Medical Device Standards Management Institute of the China Institute of Food and Drug Control (hereinafter referred to as the Institute) organized a pre-review meeting for soliciting opinions on the revision of the medical device classification catalog (the first batch) in Beijing.

It was mentioned in the meeting: The State Food and Drug Administration issued the "Medical Device Classification Rules" and they will be officially implemented on January 1, 2016. If the revision of the Medical Device Classification Catalog proceeds smoothly, the new version of the "Medical Device Classification Catalog" is expected to be released this year!

In addition, relevant people also disclosed specific progress:

1. A working group for the revision of the medical device classification catalog has been formed, staff and office conditions have been equipped, and the revision work is on the way.

2. The original 43 medical device sub-categories have been adjusted to the current 22 sub-categories, and the revision of 11 sub-categories has been initially completed. The first draft of the relevant sub-categories has been completed ahead of schedule, and the revision progress is much faster than expected.

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

4. The dynamic database required for catalog revision has been established, and the medical device registration data information involved in the classification catalog revision has been organized and extracted.

So what is the impact on medical device companies?

As we all know, my country's medical device classification implements a classification catalog system guided by classification rules. Classification rules and classification catalogs coexist, and the classification catalog takes priority.

Medical device classification is the basis and source of medical device management. The new version of the "Medical Device Classification Rules" has been introduced and implemented, but because it is relatively macro and abstract in content, it is still difficult to directly apply it to classify new products.

The release of the new version of the "Medical Device Classification Catalog" will be a timely rain, relieving many companies that are troubled by classification problems.

The new version of the medical device classification catalog will clarify the ownership of some products and directly guide the R&D registration and production of enterprises. The product descriptions, intended uses, product name examples of each subcategory in the new version of the medical device classification catalog will further guide companies to correctly classify products, so as to facilitate their future market layout.