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Brazil’s ANVISA issued a new regulation for custom-made medical devices that includes new requirements for manufacturing, marketing and importing such devices. Read More
Marcelo do Ó, managing director and partner at L.E.K. Consulting, in São Paulo, Brazil, talked with FDAnews about recent changes by Brazil’s National Surveillance Agency. Read More
Brazil’s National Agency for Sanitary Vigilance is seeking industry comments on a proposal that would extend licenses for medical devices from five years to 10 years. Read More
Olympus will cough up a total of $646 million to settle two investigations for making illegal payments to doctors and hospitals in the U.S. and Latin America. Read More
Brazil’s ANVISA has issued new regulations defining registration requirements for medical devices and in vitro diagnostics that likely will require industry to revise technical documents by Oct. 26. Read More
Following the international thawing of relations with Iran, Brazil’s Ministry of Development, Industry and Foreign Trade and Brazilian Trade and Investment Promotion Agency conducted a prospective trade mission to that country, with medical devices and hospital equipment being one of the areas of focus. Read More
Officials from the Agência Nacional de Vigilância Sanitária met with health and economic representatives from France last week to discuss the economic regulation of medical products and pricing models in Brazil. Read More
Peruvian health officials have amended regulations related to medical devices in a move that could prove beneficial for foreign and domestic manufacturers. Read More
The Japan External Trade Organization and that country’s Pharmaceuticals and Medical Devices Authority are looking to enhance ties with Brazil’s Agência Nacional de Vigilância Sanitária on medical products regulations. Read More