The purpose of obtaining Class B medical device registration under the Hong Kong MDACS is to ensure that low-to-moderate risk medical devices meet the safety, quality, and performance standards required for marketing and use in Hong Kong. Specifically, it serves to:

1. Protect Public Health and Safety
   Registration verifies that the device is safe and effective for its intended use, minimizing risks to users.

2. Ensure Regulatory Compliance
   It confirms that manufacturers, importers, and distributors comply with Hong Kong’s medical device regulations under the MDACS framework.

3. Enable Legal Market Access
   Registered devices are legally allowed to be imported, sold, and distributed in Hong Kong.

4. Facilitate Market Surveillance
   Authorities can monitor registered devices for adverse events, recalls, or safety issues post-market.

5. Promote Accountability
   The process requires appointing a Local Responsible Person (LRP), ensuring there is a local point of contact responsible for regulatory matters.

In short, Class B registration provides confidence to regulators, healthcare providers, and patients that the device is safe and compliant with local requirements.

If you want, I can help explain the benefits of registration or how it supports your business strategy. Would you like that?

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