Examples: HIV antibody tests, HLA typing kits 🧪 Needs assessment by a Recognized Certification Body (RCB) .
📌 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 .
Vitamin B12 tests, pregnancy self-testing kits, or cholesterol tests. High Individual / Moderate Public Health Risk hong kong ivd classification
Another company, MedTech, developed an IVD test for diagnosing a life-threatening infectious disease. The test was highly complex, requiring advanced algorithms and sophisticated software. Due to its high-risk nature, the MDCO classified it as a Class C device. As a Class C device, the test kit underwent rigorous regulatory scrutiny, including thorough reviews of clinical data, technical documentation, and manufacturing processes.
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 Examples: HIV antibody tests, HLA typing kits 🧪
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
Hong Kong follows a for IVDs, closely aligned with the Global Harmonization Task Force (GHTF) principles: High Individual / Moderate Public Health Risk Another
Tests for HIV, Hepatitis B (HBV), or blood grouping (ABO/Rh). Classification Rules and Principles