In order to market a medical device in Argentina, you must first register this device with the local health authority, ANMAT. In order to complete this registration several steps must be followed.
Step 1: Determine whether your device will be eligible to bypass GMP assessment:
When registering a medical device in Argentina, you may need to undergo a Good Manufacturing Practices (GMP)assessment, depending on your country of origin. Manufacturers from certain countries can skip this requirement if they meet specific criteria established by ANMAT. These countries typically include those with a robust regulatory framework and recognized health authorities, such as:
- United States
- European Union
- Canada
- Japan
- Australia
- South Korea
Step 2: Determine device classification:
This classification may reference standards from the country of origin or the Free Sale Certificate (FSC) used as a benchmark in Argentina. Understanding how your device is classified elsewhere can provide valuable context for its registration in Argentina. The classifications are:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Step 3: Compile dossier:
Gather the required documents, which typically include, among other requirements:
- Product information and labeling
- Quality management system documentation (e.g., ISO 13485)
- Free sale certificate from the country of origin
Dossiers must be prepared and submitted in the manner set out by ANMAT and it is therefore recommended to consult with a local regulatory professional to successfully navigate this step.
Step 4: Appoint a local representative:
Foreign manufacturers must appoint a local representative to present their submission before ANMAT. This local company will later be the owner of the registration in Argentina, and the only one authorized to import the product to the region, as such it is recommended to choose this company carefully.
Step 5: Registration submission:
This action will be performed by the Local Representative. They will take the information compiled in step 3 and submit it using ANMAT’s online system.
Step 6: Await approval:
The estimated time for approval varies based on the risk classification. Between 4 and 8 months is a good estimated time for approval. During this time, ANMAT may reach out to the manufacturer (through the Local Representative) for clarification or extra details.
Step 7: Receive approval:
Once ANMAT is satisfied of the devices safety, they will supply a certificate of such, allowing the manufacturer to market the device within Argentina.
Step 8: Ensure ongoing compliance:
After approval, there is a burden on the manufacturer to stay informed of regulatory changes in order to continue to maintain compliance with ANMAT’s regulations.
Conclusion
Navigating the regulatory landscape for medical device registration in Argentina can be complex and often overwhelming. That’s where LAMA comes in. We specialize in providing tailored regulatory and commercial support services for businesses looking to enter the Latin American market.
Understanding how to classify your device is crucial, as it influences everything from documentation requirements to your overall registration strategy. Our experienced team can guide you through this process, ensuring that you select the appropriate classification and provide all necessary documentation listed on our handy checklist.
Our in house regulatory team will ensure your submission is complete and complies with all regulatory requirements, preventing any delays in the approval process. We will follow up with ANMAT, bridging the language and knowledge barriers that may exist. At LAMA, we also offer the service of local representative. We can deal with this as a purely regulatory function or, as we recommend, use this service to begin to merge regulatory and commercial strategy. For more information on this, contact LAMA today.
Stay tuned for our next article, where we’ll explore the registration process for medical devices in Brazil. At LAMA Access, we are committed to making your journey into Latin America smooth and successful. Let us help you navigate these challenges and take your projects to the next level!
If you’re considering expanding your brand into the LATAM market, our consultancy is here to support you every step of the way, including in the exciting realm of nanomedicine and cosmetics. Together, we can unlock the full potential of your brand in this vibrant and growing market.