Hong Kong Ivd Classification | Top 20 VALIDATED |

Hong Kong follows a for IVDs, closely aligned with the Global Harmonization Task Force (GHTF) principles:

👉 Let us know in the comments: Are you planning to list your IVD in Hong Kong under MDACS, or are you comparing it with other Asian regulatory pathways?

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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.

Vitamin B12 tests, pregnancy self-testing kits, or cholesterol tests. High Individual / Moderate Public Health Risk hong kong ivd classification

Examples: Specimen containers, general culture media ✅ No Notified Body involvement required.

, In Vitro Diagnostic (IVD) medical devices are regulated by the under the Medical Device Administrative Control System (MDACS) . The classification system is risk-based, aligning with international standards from the IMDRF (formerly GHTF). IVD Classification Risk Levels Hong Kong follows a for IVDs, closely aligned

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