Central & South America - February 2018

Brazil: Medical device registrations valid for 10 years instead of five years
Brazil: Good Manufacturing Practice certification of foreign medical device manufacturers
Brazil: Importation process for medical devices has been simplified
Brazil: Criteria and processes for importing unregistered medical devices
Brazil: Mandatory inclusion of standard barcodes on traceability tags for cardiac stents, and hip and knee implants proposed
Brazil: Updated list of technical standards to be adopted in the certification of conformit

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