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    Market approval of medical devices in LATAM

    Latin America (LATAM) is a very attractive market for the medical device industry due to its size and the high dependence of the healthcare systems on the import of high-technology medical devices from Europe, North America and Asia. However, entering and staying in the market can be quite challenging for manufacturers since medical device regulations are not harmonized throughout LATAM, constantly evolving and often only available in either Portuguese or Spanish. On top of that, communication with marketing registration holders, local consultants and distributors are generally far from ideal, leading to outdated processes and delayed reaction to post-market surveillance issues.

    In this context, it is essential to understand the regulatory landscape in the region, optimize registration dossiers and create streamlined procedures that facilitate the communication with all relevant stakeholders.

    Join our seminar to understand the role of MERCOSUR (Southern Common Market) in the regulatory landscape and expand your knowledge on the current requirements for product registration, quality management systems and post-market surveillance in Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA) and Argentina (ANMAT). Take advantage of this online seminar for building a successful market access strategy for LATAM and effectively keeping your products in the market.

    Goal of the training

    This seminar will give you a comprehensive overview of the medical device regulations in LATAM, with focus on Brazil, Mexico, Colombia, and Argentina as the region’s main markets. You will learn about the specific requirements for preparing registration dossiers, implementing quality management systems and keeping vigilance timelines. The content of the seminar will be illustrated on practical examples and further explored in discussions with the trainer.

    Your advantages of online trainings

    Our online seminars continue to offer you the opportunity to keep up to date with current topics in regulatory affairs of medical devices, despite travel restrictions.
    During the live presentation online you can communicate directly with our speakers. In order to enable an optimal knowledge transfer, the online seminar is designed for approx. 4.5 hours, so that we have enough time for your comments and questions. Furthermore, a small group of participants ensures an interesting exchange of experience among each other and with the speaker.

    Technical requirements:

    You can participate via PC, tablet or even smartphone. The only requirements are an internet connection and a standard web browser. No special software is required. Loudspeaker and a microphone ensure an interactive exchange of information during the online seminar. A headset may be helpful to suppress background noise.

    Services

    The participation fee includes the seminar documents in electronic form and proof of participation. In addition, there will of course be an opportunity for the participants to exchange experiences and discuss with our experts.

    Buchung

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