Hong Kong Ivd Classification 2021 -

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.

Blood glucose self-testing monitors, HLA typing tests, or PSA screening. High Individual & High Public Health Risk hong kong ivd classification

General laboratory reagents, plain urine cups, or specimen receptacles. Moderate Individual / Low Public Health Risk

Lena, a medical device manufacturer, developed a simple IVD test kit for self-monitoring blood glucose levels. The kit was designed for single-use and had a straightforward testing procedure. After reviewing the product's specifications and intended use, the MDCO classified it as a Class A device, which carries the lowest risk. As a Class A device, the test kit required minimal regulatory documentation and was subject to a simple registration process. Examples: HIV antibody tests, HLA typing kits 🧪

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

Tests for HIV, Hepatitis B (HBV), or blood grouping (ABO/Rh). Classification Rules and Principles High Individual & High Public Health Risk General

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