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.
👉 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 ivd classification
Unlike Mainland China’s NMPA (formerly CFDA) risk-based classification (Class I to III), Hong Kong currently operates under the – a voluntary but widely adopted framework. If you’re involved in bringing In Vitro Diagnostic
🔬
📢 Navigating Hong Kong’s IVD Classification: What You Need to Know hong kong ivd classification