Class B medical device registration under the Hong Kong MDACS means:

Meaning of Class B Medical Device Registration under Hong Kong MDACS

• Classification Context:
  The Hong Kong Medical Device Administrative Control System (MDACS) classifies medical devices based on risk levels into Class A, B, C, and D — with Class A being the lowest risk and Class D the highest.

• Class B Definition:
  Class B devices are considered low-to-moderate risk medical devices. They require registration and approval before being marketed or imported in Hong Kong, but their regulatory controls are less stringent compared to higher-risk classes (C and D).

• Registration Purpose:
  Registering a Class B device ensures it meets safety, performance, and quality standards required by the Hong Kong Department of Health. It allows authorities to monitor devices placed on the market and protect public health.

• Implications:
  Manufacturers or importers must comply with specific documentation, safety testing, labelling, and quality management requirements. They must also appoint a Local Responsible Person (LRP) in Hong Kong for regulatory communication.

• Regulatory Control:
  After registration, the device can legally be imported, distributed, and sold in Hong Kong under the conditions defined by the MDACS.

If you want, I can explain how Class B compares with other device classes in Hong Kong or the specific requirements for Class B devices. Would you like that?

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