For Class B medical device registration under Hong Kong MDACS, the applicable standards generally align with internationally recognized safety, performance, and quality standards. These standards help ensure that your device is safe and effective for use.

Key Standards for Class B Medical Device Registration under Hong Kong MDACS

1. General Safety and Performance Standards

• ISO 13485: Quality management system requirements for medical device manufacturers.

• ISO 14971: Application of risk management to medical devices.

2. Electrical Safety and Performance Standards

• IEC 60601 Series: For medical electrical equipment (e.g., IEC 60601-1 for general safety, IEC 60601-1-2 for electromagnetic compatibility).

3. Biocompatibility Standards

• ISO 10993 Series: Biological evaluation of medical devices to assess biocompatibility (e.g., cytotoxicity, sensitization, irritation).

4. Software and Cybersecurity (If Applicable)

• IEC 62304: Medical device software lifecycle processes.

• ISO/IEC 27001: Information security management (if relevant).

5. Labeling and Usability Standards

• ISO 15223-1: Symbols for medical device labeling.

• ISO 14971: Also relates to usability and risk.

6. Specific Device Standards

• Depending on the device type, additional device-specific standards may apply (e.g., ISO 80369 series for connectors, ASTM standards for certain materials).

Important Notes:

• MDACS accepts compliance with international standards commonly used in major regulatory jurisdictions such as the EU (CE marking) or the US (FDA).

• If your device is already certified or approved under these recognized standards by other authorities, it can simplify the MDACS registration process.

• The exact standards required depend on the device type and its intended use. For example, an electrical therapeutic device will need IEC 60601 series compliance, whereas a non-electrical device may not.

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