In our last Latin American series blog post, we introduced the diversity and complexity of the life science market in the region, with specific focus on Brazil’s regulatory body and track for medical devices. This week, continuing with our Latin American series, we are focusing on Argentina’s medical device regulatory pathway.
What is the Regulatory Body in Argentina?
Argentina’s regulatory body is called the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), and is the legal institution in place that regulates drug therapies, food, cosmetics, cleaning products, and of course medical devices. Argentina is also part of Mercosur, a “regional integration process” created to align and improve cross-border relations in Latin America. Other countries part of Mercosur include Brazil, Venezuela, Paraguay, and Uruguay.
What to Know About Argentina’s Medical Device Regulatory Pathway
Argentina’s medical device regulatory pathway is very similar to Brazil’s, consisting of 4 main classifications ranked in ascending order of risk.
|Class I||Low||Stethoscopes, bedpans, tongue depressors|
|Class II||Moderately Low||Some pregnancy tests, powered wheelchairs|
|Class III||Moderately High||Breast implants, dialyzers|
|Class IV||High||Pacemakers, coronary stents|
For medical device companies to submit their application to register their product, they must follow ANMAT’s regulatory pathway for approval:
- Argentina Authorized Representative (AAR): ANMAT requires a local representative for the medical device company seeking authorization to be the point of contact throughout the registration process. AARs must obtain ANMAT Good Manufacturing Practices (GMP) certification that covers the device for submission, as well as hold an authorized permit. For Class II, III, IV devices, as well as IVDs, AARs will submit:
- Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG)
- History of commercialization
- Proof of payment for registration fee
- Mercosur declaration of conformity
- Affidavit for reporting recalls as well as Field Safety Corrective Actions
Note: For Class I devices, AARs only need to submit proof of payment, manufacturer information, and Mercosur declaration of conformity.
- Certificate of Free Sale (CFS)/Certificate to Foreign Government: A CFS or CFG must be supplied by a recognized authority from a country with agreements with ANMAT that holds information on the medical device and its applicable accessories as well as the name of the manufacturer.
- Spanish Translation of Dossiers: All documents submitted to ANMAT must be in Spanish. In addition, dossiers submitted to ANMAT must have: device classification, instructions for use (IFU), labeling, information about the manufacturer, and a technical file.
Important Considerations for MedTech Companies
For medical device companies looking to expand into Argentina’s diverse market, there are several important factors to take into consideration:
- Mercosur Common External Tariff (AEC): All imported medical devices are taxed due to AEC. The range of tax depends on if the product is refurbished (0%-24%) or not (0%-16%).
- VAT Tax: When a medical device is purchased, there is a VAT tax added. The range of tax depends on the product’s insurance, cost, and freight (CIF) value.
- Review Time & Validity: The standard time for review of submissions is 180 days. Typically, however, Class I medical devices are reviewed within 30-60 days, and all other devices could take up to one year. If products are approved, the validity time in the Argentinian market is 5 years.
- Post-Market Surveillance: Medical device manufacturers must monitor and report any recalls on their products as well as conduct post-market studies.
There are many benefits for MedTech companies looking to expand to Latin America, particularly in Argentina. The import market for medical devices in 2017 totaled to be $840 million USD, comprising 82% of the entire market, clearly demonstrates this region poses advantageous opportunities for MedTech companies seeking growth in diverse markets. For MedTech companies unsure where to start, it’s important for them to choose the right partner to help navigate not only regulatory submissions, but also ensure accurate and high-quality translations of all technical documentation being submitted to ANMAT.
If you’re interested in learning more about the Latin American market for the life sciences industries, join us at the DIA 2021 Global Annual Meeting, where sessions will include clinical trials in Latin America! Be sure to visit our booth while you’re there. Also be sure to also stay tuned for the next installment of our LATAM series to learn more about the diverse market’s regulatory landscape, clinical trials, and more!