Hong Kong Ivd Classification [VERIFIED]

The Hong Kong Medical Devices Control Office (MDCO) regulates medical devices, including In Vitro Diagnostics (IVDs), under the Medical Devices Ordinance. The MDCO classifies IVDs based on their risks, with the classification determining the level of regulatory control.

Blood glucose self-testing monitors, HLA typing tests, or PSA screening. High Individual & High Public Health Risk hong kong ivd classification

Unlike Mainland China’s NMPA (formerly CFDA) risk-based classification (Class I to III), Hong Kong currently operates under the – a voluntary but widely adopted framework. The Hong Kong Medical Devices Control Office (MDCO)

Tests for HIV, Hepatitis B (HBV), or blood grouping (ABO/Rh). Classification Rules and Principles High Individual & High Public Health Risk Unlike

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Is this IVDMD intended for use in detecting the presence of an infectious agent if there is a significant risk that an erroneous r... Show all Class A (Low Risk): Minimal risk to both individuals and public health. Examples: General laboratory reagents, plain specimen cups. Note: Class A devices generally do not require listing under the MDACS. Class B (Moderate Individual / Low Public Health Risk): Moderate risk to an individual but low risk to the public. Examples: Vitamin B12 tests, home pregnancy kits, urine test strips. Class C (High Individual / Moderate Public Health Risk): Significant risk to the individual if an error occurs, or moderate public health risk. Examples: Blood glucose self-testing devices, HLA typing for organ matching, cancer screening tests (PSA). Class D (High Individual & High Public Health Risk): The highest risk category, often involving transmissible agents. Examples: Tests for HIV, Hepatitis B (HBV), and blood grouping for transfusion. Emergo by UL +5 How to Determine Your Device’s Class The primary resource for classification is the Technical Reference TR-006 , which outlines specific rules based on the device's

, 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