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

Click here for the full article on Global Regulatory Press.

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