Medical Device and IVD Registration and Approval in Hong Kong
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 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. Medical Device and IVD Registration and Approval in
: The manufacturer's stated purpose is the primary factor. Class D High individual and public health risk
📌 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 .