Hong Kong Ivd Classification [exclusive] Jun 2026

Examples: HIV blood donor screening, Hepatitis C nucleic acid tests 🚨 Strictest scrutiny – mandatory RCB certification + possible batch testing.

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Examples: Specimen containers, general culture media ✅ No Notified Body involvement required. hong kong ivd classification

The Hong Kong IVD classification system ensures that medical devices, including IVDs, are evaluated and regulated according to their risks, providing a framework for manufacturers to develop and market their products while ensuring patient safety. Examples: HIV blood donor screening, Hepatitis C nucleic

Tests for HIV, Hepatitis B (HBV), or blood grouping (ABO/Rh). Classification Rules and Principles Tests for HIV, Hepatitis B (HBV), or blood grouping (ABO/Rh)

The MDD provides specific rules in to help manufacturers determine the correct class for their device. The classification depends on several factors: Hong Kong Medical Device Classification | Asia Actual, LLC

Hong Kong utilizes a four-tier classification system for IVD medical devices, ranging from Class A (lowest risk) to Class D (highest risk). This system aligns with international principles established by the International Medical Device Regulators Forum (IMDRF). Risk Level Example Devices Low Individual & Public Health Risk