Brazil Develops Two-Step Process to Certify Electromedical Devices

To get a conformity assessment (CA) certificate for electromedical devices in Brazil, importers and distributors must provide the government with recent test reports for all applicable International Electrotechnical Commission standards, according to a new regulation. The testing requirement is part of a two-step process for CA certification that also includes evaluation of a company’s quality management system. The regulation, issued by Brazil’s National Institute of Metrology, Standardization and Industrial Quality, replaces a 2006 rule.
International Medical Devices Regulatory Monitor