Hong Kong Ivd Classification |link| -

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

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

: Only Class B, C, and D IVDs are currently eligible for listing; Class A is exempt. Regulatory Requirements Is this IVDMD intended for use in detecting

IVDs are categorized into four classes based on their potential risk to individuals and public health: Risk Level Low individual and public health risk General lab instruments, plain urine cups. Class B Moderate individual / Low public health risk Vitamin B12, pregnancy tests, blood glucose monitors. Class C High individual / Moderate public health risk HLA typing, PSA screening, Rubella testing. Class D High individual and public health risk HIV, Hepatitis B/C, and blood group (ABO) tests. Key Classification Principles Note: Class A devices generally do not require

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.

📌 Refer to the MDD’s “Guidance Notes on Classification of IVD Medical Devices (GN-02).” When in doubt, the default rule is to apply GHTF’s classification rules 1 to 8 .

Understanding is essential for manufacturers seeking to enter one of Asia’s most dynamic healthcare markets. Regulated by the Medical Device Division (MDD) under the Medical Device Administrative Control System (MDACS), In Vitro Diagnostic (IVD) devices are categorized based on their level of risk to both individuals and public health. The 4-Tier Risk Classification System