Regulatory Insights & Updates

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How to Appoint a Local Responsible Person (LRP) in Hong Kong
Medical Devices and IVDsMay 25, 2026

How to Appoint a Local Responsible Person (LRP) in Hong Kong

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Technical Documentation Requirements for Medical Device Registration in Hong Kong
Medical Devices and IVDsMay 25, 2026

Technical Documentation Requirements for Medical Device Registration in Hong Kong

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MFDS Medical Device Classification in South Korea
Medical Devices and IVDsMay 21, 2026

MFDS Medical Device Classification in South Korea

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Understanding SFDA’s New Bundling Criteria for Medical Devices within a Single MDMA Application
Medical Devices and IVDsMay 18, 2026

Understanding SFDA’s New Bundling Criteria for Medical Devices within a Single MDMA Application

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Korea License Holder (KLH) Requirements for Medical Devices in South Korea
Medical Devices and IVDsMay 12, 2026

Korea License Holder (KLH) Requirements for Medical Devices in South Korea

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KGMP Certification for Medical Devices in South Korea – Step-by-Step Process
Medical Devices and IVDsMay 11, 2026

KGMP Certification for Medical Devices in South Korea – Step-by-Step Process

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