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
📢 Navigating Hong Kong’s IVD Classification: What You Need to Know hong kong ivd classification
The MDD provides specific rules in to help manufacturers determine the correct class for their device. The classification depends on several factors: Hong Kong Medical Device Classification | Asia Actual, LLC IVDs are categorized into four classes based on
Hong Kong utilizes a four-tier classification system for IVD medical devices, ranging from Class A (lowest risk) to Class D (highest risk). This system aligns with international principles established by the International Medical Device Regulators Forum (IMDRF). Risk Level Example Devices Low Individual & Public Health Risk Class D High individual and public health risk
: Only Class B, C, and D IVDs are currently eligible for listing; Class A is exempt. Regulatory Requirements
: If multiple rules apply, the device falls under the highest classification.
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.