Webinar: Best Practices To Register Medical Devices in Argentina |
In today's webinar led by Priya Bhutani, an overview of the medical device regulatory landscape in Argentina was provided.
Key points included:
Regulatory Framework: Argentina’s medical device regulations are similar to the European Medical Device Directive, categorizing devices into four risk classes (Class I to IV). In-vitro diagnostics (IVDs) have their own classification but are also recognized as medical devices.
Approval Pathways: Companies with FDA or CE mark certifications may experience easier registration processes in Argentina. However, companies must still comply with local regulations and obtain authorization from the National Regulatory Authority (ANMAT).
Combination Products: Argentina does not have specific regulations for combination products; they are classified under either medical device or IVD regulations based on their primary intended use.
Role of Authorized Agents: Authorized agents in Argentina act as importers and are crucial for product registration. They must have local presence and comply with Good Manufacturing Practices (GMP).
Post-Market Surveillance: Companies must have procedures for post-market surveillance and are required to report any adverse events, whether they occur in Argentina or globally.
Import Requirements: There are specific importation requirements, including permits and certificates, that must be fulfilled for both registered and non-registered products.
The session concluded with an invitation for questions and feedback, emphasizing the importance of local regulatory knowledge for successful market entry.