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This is a Literature Review study.

Global Regulatory Frameworks for In-vitro Diagnostics IVDs: A Comparative Analysis and Future Outlook

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Review reveals IVD regulatory frameworks impact market access in diverse regions, suggesting compliance is crucial for safety.

In-vitro diagnostics play a vital role in healthcare, enabling early detection and informed treatment decisions.
The global IVD market is expanding rapidly due to technological innovations and increased healthcare demands.
Regulatory frameworks vary widely across regions, influencing the lifecycle and market access of IVDs.
Balancing innovation with compliance remains essential, especially as IVDs integrate with combination products.

S. et al. (2025) studied this question.

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