『Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators』のカバーアート

Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators

Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators

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Brazil's MedTech market offers immense growth opportunities, but entry is guarded by the complex dual-gatekeeper system of ANVISA and INMETRO. This episode of MedTech Global Insights demystifies this process, revealing the common and costly pitfalls that international manufacturers face when seeking certification and registration for their medical devices. We move beyond theory to discuss what defines a truly effective regulatory partner in this challenging landscape. It is not just about submitting documents. it is about a holistic strategy that integrates technical INMETRO certification with ANVISA's rigorous regulatory demands, secures your market access through independent representation, and leverages technology to ensure speed and accuracy. A real-world example: Imagine spending a year and a significant budget preparing your device registration for ANVISA, only to have it rejected on day one. The reason? Your company was completely unaware that your electrical device required a separate, mandatory INMETRO certification *before* ANVISA would even look at your file. This single oversight just reset your market entry timeline, pushing your launch back by at least another 18 months. Key Takeaways: - Why is the INMETRO certification a critical first step that trips up so many foreign manufacturers? - What are the legal and commercial dangers of appointing a distributor as your Brazil Registration Holder (BRH)? - How does your device's risk classification directly impact the need for a costly Brazilian Good Manufacturing Practice (BGMP) audit? - Which specific documents in a technical dossier are most scrutinized by ANVISA inspectors? - How can AI-powered platforms accelerate the creation and submission of complex regulatory files for Brazil? - What is the realistic timeline for achieving both INMETRO and ANVISA approval, and where do the biggest delays typically occur? - Why is an integrated approach covering both technical compliance and regulatory affairs essential for success in Brazil? To navigate these challenges and unlock the Brazilian market, contact us at info@pureglobal.com or visit https://pureglobal.com/
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