While the regulations for face masks will vary by country or region, compliance also depends on the type of face mask and the way it is marketed.
Surgical masks and respirators are regulated most often as medical devices, whereas community masks, designed for personal use, are largely unregulated.
Due to an increase in counterfeit and substandard products, China temporarily imposed additional regulatory requirements on five types of medical devices to be exported, including COVID-19 test kits, surgical masks, surgical preventive clothing, ventilators and infrared thermometers.
A leading Japanese medical device company wanted to expand its line of face masks to Europe during the coronavirus pandemic. The client wanted to include an on-label pollution blocking claim.
RegASK worked with its on-the-ground experts with insider knowledge of the EU to ensure product entry into the maximum number of countries possible.
Navigate complex regulatory terrain even when the map keeps changing.
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In emerging markets, where regulations are fast evolving and sometimes subject to interpretation, our experts help you understand and navigate the laws.