新版《儿童玩具分类目录》预计将在今年出台

 新闻资讯     |      2020-06-28 14:03:13
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.

中国食品药品检定研究院医疗器械标准管理研究所(以下简称械标所)在北京组织召开了医疗器械分类目录修订征求意见(第一批)工作预审会。
 
会中提到:国家食药监总局发布了《医疗器械分类规则》,并于2016年1月1日起正式施行。如果医械分类目录修订工作顺利进行的话,新版《医疗器械分类目录》预计将在今年出台!
 
另外,相关人士还透露了具体进展:
 
1、医械分类目录修订工作组已经组建,人员和办公条件已经配备,修订工作已在路上。
 
2、将原有43个医疗器械子目录调整为目前的22个子目录,已经初步完成了11个子目录的修订,相关部分子目录的初稿已经提前完成,修订进度较预期要快很多。
 

3、一级目录和二级目录名称已经初步确定,且子目录框架更具有前瞻性和科学性。

4、为目录修订所需的动态数据库已经建立,分类目录修订涉及的医疗器械注册数据信息得到了整理和提取。
 
那么对医疗器械企业来说有何影响呢?
 
众所周知,我国医疗器械分类实行分类规则指导下的分类目录制,分类规则和分类目录并存,以分类目录优先的医疗器械分类制度。
 
而医疗器械分类是医疗器械管理的基础和源头。前面新版《医疗器械分类规则》已经出台实施,但由于它比较宏观,内容抽象,直接适用它来分类新产品仍有困难。
 
新版《医疗器械分类目录》的发布将是一阵及时雨,让众多被分类难题困扰的企业得到解脱。
 
新版医械分类目录将明确一些产品的归属,直接指导企业的研发注册以及生产。新版医械分类目录中各子目的产品描述、预期用途、品名举例等内容,将进一步指导企业对产品进行正确分类,以便于企业日后布局市场。