为进一步规范医疗器械强制性标准的适用范围，器审中心在2022年已发布《医疗器械产品适用强制性标准清单》（2022年第42号）（以下简称“清单”）的基础上，根据医疗器械强制性国家标准和强制性行业标准制修订情况，经商国家药品监督管理局医疗器械标准管理中心，对清单进行了修订。

　　现将修订后的文件予以发布，自发布之日起，《医疗器械产品适用强制性标准清单》（2022年第42号）同时废止。

　　特此通告。

　附件：

1.医疗器械产品适用强制性标准清单（2024年修订版）.pdf

2.医疗器械产品适用强制性标准清单（2024年修订版）使用说明.pdf

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https://www.cmde.org.cn/xwdt/shpgzgg/gztg/20240613155244118.html

For additional information regarding this alert, please contact:

VSCB Specialists
 Email：Lisa.liu@vscbcorp.com

The following is an unofficial translation

subject: Circular on the Publication of the List of Mandatory Standards Applicable to Medical Device Products (Revised version 2024) (No. 20 of 2024)

Content: In order to further standardize the scope of application of mandatory standards for medical devices, the Center has issued the List of Mandatory Standards for Medical Device Products (No. 42 in 2022) (hereinafter referred to as the "List") in 2022, based on the revision of mandatory national standards for medical devices and mandatory industry standards. Doing business with the Medical Device Standard Management Center of the State Drug Administration has revised the list.

The revised document is now issued, and from the date of publication, the List of Mandatory Standards for Medical Device Products (No. 42 of 2022) is repealed at the same time.

We hereby inform you.

Annex: 1. List of Mandatory Standards Applicable to Medical device Products (2024 revision)

2. List of mandatory standards applicable to medical device products (revised version 2024) Instructions for use

Related website links:

https://www.cmde.org.cn/xwdt/shpgzgg/gztg/20240613155244118.html

For additional information regarding this alert, please contact:

VSCB Specialists
 Email：Lisa.liu@vscbcorp.com