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Mar 27, 2020 · For two of the largest markets, the testing and certification requirements for USA (ASTM) and Europe (EN) are detailed in the table below: Temporary CE marking Exemption RECOMMENDATION (EU) 2020/403 of 13 March 2020 was released within the context of the COVID-19 threat to address the shortage of surgical face masks.

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No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.

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No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.

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Face Mask Regulations and Standards in the US: An Overview

With that said, if you are planning to import and sell face masks in California, you shall verify the restricted substance in your product, which can be done by third-party companies such as SGS and TUV. Country of Origin. In the US, it is mandatory to affix the country of origin label on imported products, including face masks.

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