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Face Mask Regulations and Standards in the EU: An Overview

Compliance Risks. Far from all medical and protective face masks on the market are designed to comply with EU standards and regulations. It’s therefore essential to request and verify all relevant compliance documents and lab test reports, and product labels, before importing face masks from suppliers in China, or other countries.

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Product Recalls | SGS

Our Product Recalls online platform brings together the latest unsafe product notifications (non-food) published by official authorities operating in the European Union (RAPEX and RASFF), the United States (CPSC and FDA), Canada (Health Canada) and Australia (ACCC).

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Face Mask Regulations and Standards in the US: An Overview

COVID-19 FDA Exemptions Due to Mask Shortages in the United States. Due to the current situation, the FDA is currently accepting the import N95 respirators that aren’t approved by NIOSH, but which are approved by authorities in the EU, China, Japan, Korea, Mexico, Australia, or Brazil.

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The new European medical devices legislation, MDR, should replace the current Medical Devices Directive from May 26, 2020. However, as a result of a lack of designated Notified Bodies, coupled with Brexit and COVID-19 pandemic the EU has proposed a one-year delay to the Date of Application.

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SafeGuards – Regulatory Updates | SGS Mexico

AFNOR Releases General Purpose Mask Standard. 22 Apr 2020 Softlines. The French association, AFNOR, has released AFNOR SPEC S76-001 “Masques barrières" or “Barrier Masks” (in English), a standard that establishes minimum requirements for non-medical general purpose masks

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SafeGuards – Regulatory Updates | SGS Spain

The new European medical devices legislation, MDR, should replace the current Medical Devices Directive from May 26, 2020. However, as a result of a lack of designated Notified Bodies, coupled with Brexit and COVID-19 pandemic the EU has proposed a one-year delay to the Date of Application.

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