THE NEW APPROACH FOR PERSONAL PROTECTIVE EQUIPMENT (PPE) EVALUATION IN BRAZIL: From Single Test Analysis to Risk-Based Conformity Certification

Abstract

Brazilian regulation for Personal Protective Equipment (PPE) has shifted from an approach based almost exclusively on single-shot tests to a risk-proportional certification system consolidated by the General Regulation for PPE Certification (RGCEPI) issued under Ordinance MTP nº. 672/2021. This change stems from a Regulatory Impact Analysis that revealed critical shortcomings in maintaining conformity after the Approval Certificate (CA) was granted. The new framework ranks risk in three categories, links each level to graduated conformity-assessment models (1a, 4 and 5), and transfers full regulatory authority from Inmetro to the Ministry of Labor and Employment, while that institute remains responsible for accrediting certification bodies and test laboratories. Preliminary results from the first year of the new regulation implementation show a 22% drop in CA requests, an expanded network of certification bodies, and the first regulatory-quality metrics. Future challenges include enlarging testing capacity, strengthening post-market surveillance, and dynamically updating RGCEPI annexes.