Central and South America - Feb 2021

Argentina: ISO 13485 and MDSAP certificates accepted to support GMP compliance
Argentina: Extension of emergency registration mechanism for critical medical products; process for transitioning to full registration
Argentina: Further extension of exceptions for imported masks, gloves and IR thermometers
Brazil: INMETRO certification requirements are revised
Colombia: Forms for medical device registration updated
Mexico: Five-day review timeframe set for certain device applications
Peru: Certain expired GMP Certificates will be accepted for a limited time

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