The Institute of Medical Device Standard Management (hereinafter referred to as the Machinery Standards Institute) of the China Food and Drug Administration has organized a pre-review meeting for the solicitation of opinions (the first batch) of medical device classification catalogs in Beijing.
It was mentioned in the meeting: The State Food and Drug Administration issued the "Classification Rules for Medical Devices", which will be officially implemented on January 1, 2016. If the revision of medical equipment classification catalogue goes smoothly, the new version of "Medical Device Classification Catalogue" is expected to be released this year!
In addition, relevant persons also revealed specific progress:
1. 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.
2. The original 43 medical device sub-catalogs have been adjusted to the current 22 sub-catalogs. The revision of 11 sub-catalogs has been completed. The preliminary drafts of related sub-catalogs have been completed in advance. The revision progress is much faster than expected.
3. The names of the primary and secondary directories have been preliminarily 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 catalog revision has been collated and extracted.
So what impact does it have on medical device companies?
As we all know, my country's medical device classification implements a classification catalog system under the guidance of classification rules. The classification rules and the classification catalog coexist, and the medical device classification system that gives priority to the classification catalog.
The classification of medical devices 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, it is still difficult to apply it directly to classify new products.
The release of the new version of the "Category of Medical Device Classification" will be a timely rain, which will relieve many enterprises that are troubled by the classification problem.
The new medical equipment classification catalog will clarify the attribution of some products and directly guide the R&D registration and production of enterprises. The product description, expected use, and product name examples of each sub-item in the new version of the medical equipment classification catalog will further guide enterprises to correctly classify products in order to facilitate their future market deployment.