Drugdu.com expert's response:

In general, ordinary “civilian masks / non-medical masks” exported to Brazil are usually not regulated as medical devices or subject to INMETRO certification in the same way. It should also not be simply assumed that “all masks must obtain INMETRO certification.”

The key is to first determine how the product is positioned in Brazil:

I. If it is a civilian protective mask / non-medical mask

This type of mask is generally closer to a consumer product or textile-based protective product. It should not claim medical use, surgical use, antiviral treatment, disease prevention, or other medical functions.

The main compliance focus is usually on labeling, Portuguese instructions, materials, product safety, and the responsibility of the importer. Whether specific testing is required depends on the Brazilian importer and local regulatory requirements.

II. If it is a medical surgical mask

Then it is no longer an ordinary civilian mask. It may fall under ANVISA’s medical product regulation and needs to comply with relevant Brazilian standards.

ABNT NBR 15052:2021 applies to masks used for dental, medical, and hospital purposes, which are commonly referred to as surgical masks. It applies to both domestically produced and imported products in Brazil.

III. If it is an N95 / PFF2 or similar respiratory protective mask

This type of product is more likely to be classified as occupational respiratory protective equipment. It may involve Brazilian labor protection equipment compliance requirements, rather than only being treated as an ordinary civilian mask.

The product category, intended use claims, and sales channels through the importer need to be confirmed separately.

IV. INMETRO is not a universal certification for all products

INMETRO certification in Brazil includes both mandatory and voluntary certification. Whether it is mandatory depends on whether the product falls within the relevant mandatory conformity assessment scope.

The U.S. Commercial Service’s Brazil trade guide also states that regulated products usually require testing and certification by bodies accredited by INMETRO, and testing is usually conducted in Brazil. However, this does not mean that all civilian masks must obtain INMETRO certification.