👉 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?

📢 Navigating Hong Kong’s IVD Classification: What You Need to Know

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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 (IVD) devices to the Hong Kong market, understanding the local classification system is your first critical step.