As we all know, the classification of medical apparatus in our country implements the classification catalog system under the guidance of the classification rules. The classification rules and the classification catalog coexist, and the classification catalog gives priority to the classification system of medical apparatus. On July 14, 2015, the State Food and Drug Administration issued the "Classification Rules of Medical Apparatus", which came into effect on January 1, 2016. If the revision of the medical apparatus classification catalog goes well, the new version of the "Classification Catalog of Medical Apparatus" is expected to be released this year!

修订工作高调启动

就在今年2月24日-25日，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。

Attending the meeting were not only the leaders of the medical apparatus registration management department of the State Administration, but also relevant experts and some enterprise representatives from clinical medical institutions, the medical apparatus technical evaluation center of the General Administration, relevant provincial regulatory agencies, medical apparatus testing institutions, medical apparatus evaluation institutions. From the participants, the lineup is strong. It shows that the new version of the medical apparatus classification catalog has been launched on a high-profile, which can be seen that it may be launched this year.

Revision work progress

特别值得注意的是，中检院械标所承担了医疗器械分类目录修订的组织研究工作。会上相关负责人透露了具体进展：
一是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；
二是将原有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；
三是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；
四是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。

对企业影响几何？

众所周知，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。因此新版《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，这是较旧版分类目录较为科学的进步。
分类目录修订工作是医疗器械审评审批机制改革的基础性工作，是医疗器械监管工作的大事。医疗器械分类目录的修订工作取得的进展，将医疗器械审评审批机制改革起到指导性作用。毫无疑问，这对我国今后的医疗器械监管工作具有很大的帮助！