Blood glucose self-testing monitors, HLA typing tests, or PSA screening. High Individual & High Public Health Risk
If you’re involved in bringing In Vitro Diagnostic (IVD) devices to the Hong Kong market, understanding the local classification system is your first critical step. hong kong ivd classification
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Examples: Specimen containers, general culture media ✅ No Notified Body involvement required. Blood glucose self-testing monitors, HLA typing tests, or
: If multiple rules apply, the device falls under the highest classification. : If multiple rules apply, the device falls
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
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.