Brazilian Regulator Considers Accepting Foreign GMP Certifications

Brazil’s medical device regulatory agency ANVISA may move to recognize international Good Manufacturing Practice certifications (in Portuguese) from medical device manufacturers seeking commercialization in the country.

By accepting audits and inspections carried out by international agencies and accreditation bodies, ANVISA could potentially reduce its annual Brazilian Good Manufacturing Practice (BGMP) overseas inspection workload by 70%, and foreign companies would face a less onerous registration process in Brazil.

At this stage, however, ANVISA’s proposal remains far from implementation. Regulators would first have to reform Decree No. 74.094/77—which is indeed being considered—in order to simplify registration requirements for medical devices and other products under ANVISA’s purview.

In the meantime, ANVISA has started the process of hiring 314 new employees; the additional personnel will increase ANVISA's capacity for quality system inspections, laboratory analyses and related activities, but not for one or two years as new staff must be trained.