The COVID-19 pandemic thrust the In-Vitro Diagnostic (IVD) industry into the global spotlight. This rapid ascent brought unprecedented opportunities but also triggered a wave of intense regulatory scrutiny worldwide. The old ways of bringing a diagnostic test to market are no longer viable in this new, more stringent environment.
This episode of MedTech Global Insights explores the post-pandemic regulatory landscape for IVD manufacturers. We break down the key challenges companies face when seeking international market access, from navigating the EU's rigorous IVDR to managing disparate requirements across dozens of countries. We uncover why a successful domestic launch, even under an Emergency Use Authorization, doesn't guarantee a smooth path to global expansion.
Imagine a fast-growing diagnostics company with a revolutionary testing kit. They are leaders in their home market but find their international expansion plans blocked by a wall of complex, country-specific regulations. Their team is overwhelmed, their launch is delayed, and their competitive advantage is at risk. How can they turn this multi-market challenge into a streamlined, successful global strategy?
Key Takeaways:
- How has the pandemic permanently altered the evidence required for IVD product registration?
- What are the most significant hurdles in transitioning from a US EUA to full approval in the EU under IVDR?
- Why is a 'one-size-fits-all' approach to technical documentation destined for failure in global markets?
- How can AI and data tools accelerate the creation and submission of regulatory dossiers?
- What are the hidden costs of not having local regulatory representation in key international markets?
- Is it possible to use a single, unified process to register a product in over 30 countries simultaneously?
- How do you select the right new markets for your IVD product based on your existing regulatory approvals?
- What post-market surveillance activities are now critical for maintaining compliance globally?
For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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