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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.
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.
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.