Class B medical device MDACS registration in Hong Kong means the process of officially registering a medical device classified as Class B under Hong Kong’s Medical Device Administrative Control System (MDACS) to legally market and distribute it in Hong Kong.

What does it mean in detail?

• MDACS is the regulatory system by Hong Kong’s Department of Health that controls medical devices based on their risk level.

• Medical devices are classified into Class A, B, C, or D (A = lowest risk, D = highest risk).

• Class B devices are considered low-to-moderate risk devices.

• To market a Class B device in Hong Kong, manufacturers or importers must register the device with MDACS.

• Registration requires submitting technical documentation, appointing a Local Responsible Person in Hong Kong, and paying a fee.

• Once registered, the device is officially listed and allowed to be sold in Hong Kong, subject to ongoing compliance.

Why is this important?

• It ensures that Class B medical devices meet Hong Kong’s safety and quality standards.

• It protects public health by monitoring devices on the market.

• It provides legal authorization to distribute and sell the device in Hong Kong.

If you want, I can explain the classification criteria or help you understand if your device qualifies as Class B!

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