By Stewart Eisenhart, Emergo Group
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 recently hired more than 300 new BGMP inspectors, which should hopefully help reduce inspection timeframes for device manufacturers commercializing in Brazil.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.