Facemasks 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 facemasks that also differ in their classification. In Mexico, we can define three classifications according to the facemask intention of use.
Medical use facemasks
These kind of facemasks 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 facemasks
Other types of facemasks 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 facemasks 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 facemask, including claims like killing germs.
Protective equipment facemasks
Finally, we have the third kind of facemasks, 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 facemasks 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 facemasks in Mexico depends on their characteristics and intended use. If you are interested on importing and selling facemasks and have additional inquiries, please contact us at firstname.lastname@example.org or check our guidelines.