The Institute of Medical Device Standards Management of the Chinese Academy of Food and Drug Control (hereinafter referred to as the Institute) organized a preliminary review meeting for the revision of the medical device classification catalog (first batch) in Beijing.

During the meeting, it was mentioned that the State Food and Drug Administration has issued the "Classification Rules for Medical Devices", which officially came into effect on January 1, 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!

In addition, relevant personnel also revealed specific progress:

1. The working group for revising the medical device classification catalog has been established, personnel and office conditions have been equipped, and the revision work is on the way.

2. The original 43 subcategories of medical devices have been adjusted to the current 22 subcategories, and the revision of 11 subcategories has been preliminarily completed. The initial draft of relevant subcategories has been completed ahead of schedule, and the revision progress is much faster than expected.

3. The names of the primary and secondary directories have been preliminarily determined, and the subdirectory framework is more forward-looking and scientific.

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

So what is the impact on medical device companies?

As is well known, China's medical device classification adopts a classification directory system guided by classification rules, where classification rules and classification directories coexist and prioritize the classification directory in the medical device classification system.

The classification of medical devices is the foundation and source of medical device management. The new version of the Medical Device Classification Rules has been introduced and implemented, but due to its macro level and abstract content, it is still difficult to directly apply it to classify new products.

The release of the new version of the Medical Device Classification Catalogue will be a timely rain, providing relief for many enterprises troubled by classification problems.

The new version of the medical device classification catalog will clarify the ownership of some products, directly guiding the research and development registration and production of enterprises. The new version of the medical device classification catalog will further guide enterprises in correctly classifying products, including product descriptions, expected uses, and examples of product names for each sub item, in order to facilitate their future market layout.