Face masks consist of 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 Colombia, we can define three classifications according to the face mask intention of use.
Medical use face masks
These kinds 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 INVIMA as Class I medical devices.
Non-medical use face masks
Other types of face masks are commonly used outside healthcare settings, like fabric or textile masks. In this classification, we can include masks with filters, at least one fabric layer, or washable or reusable properties. These products aren’t considered medical devices according to INVIMA regulations and reviews by its Specialized Room for Medical Devices and In Vitro Diagnostic Reagents.
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 N99, KN99 or face masks exclusively for industrial use for the protection of the airway against substances immersed in manufacturing processes.
Those products are not considered medical devices and thus, are not subject to regulations by INVIMA. However, they may comply with Colombian Official Norms.
As a conclusion, the classification and regulation of face masks in Colombia 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 contact@veraqueconsulting.com or check our guidelines.
