The Medical Imaging and Technology Alliance (MITA) conducted a series of meetings earlier this month with industry partners in Brazil to explore opportunities to harmonize international medical device standards and expand market access to MITA member companies in Brazil and Latin America.
Representatives of the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil's federal healthcare regulatory agency, who met with MITA said they were open to regulatory improvements that would provide more timely access to new medical technologies.
During the meeting, MITA discussed laboratory testing of large equipment, good manufacturing practices (GMPs), the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program (MDSAP), environmental regulations, and the acceptance of ISO 13485, which would enhance ANVISA's inspection capability and increase transparency in the inspection process.
The market in Brazil for medical devices is growing rapidly, according to MITA. State-run as well as private, nonprofit hospitals and clinics in Brazil are upgrading their equipment and look to medical device importers for advanced technologies that will improve care and lower costs.
