Face masks consist in a protective covering for the mouth and nose. They are usually made from non-woven fabric and designed to avoid spreading infectious microorganisms, such as viruses and bacteria.
In regulatory terms, there are different types of face masks that also differ in their classification. In Mexico, we can define three classifications according to the face mask intention of use.
-
Medical use face masks
These kind of face masks are often disposable, single use and typically multilayer products such as three-layer folded, N95 or KN95. They are mainly used in hospitals, clinics and research centers by healthcare professionals to avoid contamination from and for the patients or clinical samples. All protective masks for medical use are considered by COFEPRIS as Class I low risk medical devices. It is worth mentioning, that low risk medical devices require a simple registration process, mainly with administrative requirements.
-
Non-medical use face masks
Other types of face masks are represented by products commonly not used by healthcare professionals in infectious environments. In this classification, we can put disposable or washable woven or non-woven face masks for general purposes. These products are not subject to regulations as a medical device. This is applicable if they are not labeled and/or advertised with characteristics of a medical use face mask, including claims like killing germs.
-
Protective equipment face masks
Finally, we have the third kind of face masks, that includes respiratory protectors for filtrating, not only microorganisms, but also dust particles or chemicals. In this classification, we can include FFP2, N99 or KN99 face masks that are intended to provide protection for workers.
Those products are not considered medical devices and thus, are not subject to regulations by COFEPRIS. However, they may comply with Mexican Official Norms.
As a conclusion, the classification and regulation of face masks in Mexico depends on their characteristics and intended use. If you are interested on importing and selling face masks and have additional inquiries, please contact us at [email protected] or check our guidelines.