When entering the Argentine market, one of the most common questions we receive from manufacturers is: “How long will it take to get ANMAT approval for my medical device?” It’s an important question. Timelines are key when planning a launch, coordinating distribution, or setting regional goals. However, the answer depends on several factors.
At LAMA, we believe in setting realistic expectations based on experience. Below, we explain what typically affects approval times, what you can expect for each device class, and why working with a reliable regulatory partner can make all the difference.
Understanding the Process
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is Argentina’s health authority in charge of approving medical devices before they reach the market. The registration process involves presenting a complete dossier that demonstrates the device’s safety, performance, and compliance with local requirements.
The quality of this dossier has a major impact on how quickly ANMAT completes its review. A clear, well-prepared file that follows ANMAT’s expectations can move efficiently through the process, while incomplete or poorly structured submissions can cause delays.
What Affects Approval Time
There is no fixed timeline for ANMAT approval. The duration depends on a combination of internal and external factors, including:
- Dossier quality: Files that are complete, well-organized, and properly formatted are reviewed faster. Missing or unclear information often leads to questions and delays.
- Regulatory class: Higher-risk devices (Class III and IV) take longer to review because they require more detailed evaluation.
- ANMAT workload: The authority’s internal capacity and review queue can vary, especially during periods of high demand or limited staffing.
- Local representative: The local holder or regulatory partner is responsible for communication with ANMAT. Efficient coordination at this level can help avoid unnecessary waiting times.
Typical Timelines
Based on our experience handling registrations across Argentina, LAMA estimates the following average timelines:
- Class I and II devices: around 4 to 6 months
- Class III and IV devices: around 6 to 8 months
These figures are general estimates. Some approvals may take longer, while others can move faster.
For example, we recently had a high-risk (Class III) device approved in less than two months. This kind of result is exceptional and highlights the importance of strong dossier preparation. However, we recommend not to plan projects around best-case scenarios. It is safer to allow enough time in your launch schedule to avoid unexpected delays.
ANMAT Fees and Costs
The official ANMAT registration fees vary depending on device class. Currently, they are approximately:
- USD 200 for Class I and II
- USD 300 for Class III and IV
These fees may change at any time. Argentina’s economic conditions can shift quickly, and prices can be affected even when no official updates are made. Keep in mind that these are ANMAT’s own administrative fees and do not include additional costs for dossier preparation, translations, or representation.
Why a Good Regulatory Partner Matters
Having the right regulatory partner in Argentina can make the difference between a smooth approval and months of avoidable delays.
Once a dossier is submitted, the most common source of delays comes from deficiency letters issued by ANMAT. These are formal requests for clarification or additional information. If the response is incomplete or delayed, the entire process can be put on hold for an extended period.
Because ANMAT only communicates with the local representative, it is their responsibility to receive, interpret, and relay these requests to the manufacturer. If this communication is not handled clearly and promptly, valuable time can be lost.
At LAMA, we are officially approved to act as a Local Representative in Argentina, and we take this responsibility seriously. Our team ensures that every communication from ANMAT is immediately reviewed, accurately translated, and addressed without delay. We maintain direct contact with both the authority and the manufacturer to keep the process moving at every stage.
Our combination of technical expertise, attention to detail, and constant communication helps prevent small issues from turning into major setbacks. This proactive approach is one of the reasons why our clients trust LAMA to manage their regulatory processes in Argentina and across Latin America.
Final Thoughts
While approval times are an important consideration, the key to success is preparation. A complete and well-structured dossier, supported by a capable local representative, offers the best chance of a smooth and timely registration.
At LAMA, we help manufacturers approach the Argentine market with confidence. Our goal is to make access to Latin America simpler, faster, and fully compliant.
Interested in learning more about our ANMAT registration services? Contact us to discuss your project and see how LAMA can support your expansion into Argentina and beyond.