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.

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

Vitamin B12 tests, pregnancy self-testing kits, or cholesterol tests. High Individual / Moderate Public Health Risk hong kong ivd classification

Examples: HIV antibody tests, HLA typing kits 🧪 Needs assessment by a Recognized Certification Body (RCB) .

Examples: Specimen containers, general culture media ✅ No Notified Body involvement required. Another company, MedTech, developed an IVD test for

👉 Let us know in the comments: Are you planning to list your IVD in Hong Kong under MDACS, or are you comparing it with other Asian regulatory pathways?

Hong Kong follows a for IVDs, closely aligned with the Global Harmonization Task Force (GHTF) principles: As a Class C device, the test kit

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.