📢 Navigating Hong Kong’s IVD Classification: What You Need to Know
Examples: Pregnancy tests, blood glucose meters 📄 Requires Declaration of Conformity + Technical documentation.
: If multiple rules apply, the device falls under the highest classification. hong kong ivd 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.
Medical Device and IVD Registration and Approval in Hong Kong 📢 Navigating Hong Kong’s IVD Classification: What You
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
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 The MDCO classifies IVDs based on their risks,
General laboratory reagents, plain urine cups, or specimen receptacles. Moderate Individual / Low Public Health Risk