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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