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Argentina's MedTech Gateway: Unpacking ANMAT's Key Registration Rules
This episode demystifies Argentina's medical device registration process under the national regulatory body, ANMAT. We provide a detailed breakdown of the essential framework established by Disposition 9688 of 2019, covering everything from risk classification and registration pathways to the critical requirements for foreign manufacturers seeking market entry. Key Questions: • What is ANMAT Disposition 9688/2019 and why is it essential for MedTech manufacturers? • How does Argentina classify medical devices based on risk? • What are the different registration pathways for Class I, II, III…
The skinny
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