ANVISA issues new regulations for Brazilian analytical laboratories

The Brazilian National Health Surveillance Agency (ANVISA) has published Collegiate Board Resolution No. 1.039, establishing stricter criteria for analytical laboratories in Brazil. The new regulation redefines best practices for both public and private laboratories subject to sanitary inspection.

Under the new rules, institutions must maintain a Quality Management System in compliance with the ABNT NBR ISO/IEC 17025 standard. This increases oversight regarding internal processes, specifically the cleaning and maintenance of glassware and equipment. The scope of the regulation includes laboratories performing quality control tests on products such as medicines, food, cosmetics, and medical devices.

The regulatory update coincides with growth in the health sector. Data from the Brazilian Association of Innovative Health Industry shows a 4.8% increase in medical device consumption in the first quarter of 2026 compared to the previous year, with a 7.9% rise in in vitro diagnostic reagents and analyzers. Industry experts note that the adequacy of cleaning instruments is now as critical as equipment calibration for ensuring the reliability of laboratory results.