To apply for Class I medical device MDACS registration in Hong Kong, certain conditions must be met to ensure the device complies with the local regulations and standards. Below is a list of conditions that must be fulfilled:

Conditions for Applying for Class I Medical Device MDACS Registration in Hong Kong

1. Device Classification

• Your device must qualify as a Class I medical device. Class I devices are typically low-risk, non-invasive devices with minimal potential to cause harm. Common examples include:

  • Non-invasive diagnostic devices (e.g., thermometers, stethoscopes).

  • Basic medical tools and instruments (e.g., bandages, gauze).

  • Low-risk devices without any active therapeutic purpose.

Key Criteria for Class I Devices:

• Devices that are not intended for use in diagnosing, treating, or monitoring life-threatening conditions.

• Devices that do not have any critical safety risks to users or patients.

If your device is classified as higher risk (e.g., Class II or Class III), it will require a different application process, and additional documentation and evaluation will be needed.

2. Manufacturer and Local Responsible Person (LRP)

• Manufacturer Information: The manufacturer of the device must meet international standards of manufacturing practices (such as ISO 13485 for medical devices). If you are an overseas manufacturer, you need to ensure that your products comply with Hong Kong regulations.

• Local Responsible Person (LRP): If you are an overseas manufacturer, you are required to appoint a Local Responsible Person (LRP) in Hong Kong. The LRP:

  • Acts as the point of contact for the Hong Kong Department of Health (DH).

  • Submits the registration on behalf of the manufacturer.

  • Handles any regulatory matters related to the device once it is registered.

  • The LRP must be based in Hong Kong and must be registered with the Hong Kong Department of Health.

For local manufacturers, there is no need for an LRP, and they can apply directly to the Department of Health.

3. Conformity with Standards

• The device must comply with relevant international safety and performance standards. Common standards include:

  • ISO 13485 for Quality Management Systems (QMS).

  • ISO 14971 for risk management (risk analysis and mitigation).

  • IEC 60601 for electrical safety (for electrical medical devices).

If your device holds CE marking (EU conformity) or FDA clearance, these certifications can be used as part of the evidence to show conformity with Hong Kong’s requirements. Otherwise, a Declaration of Conformity to applicable safety standards will be necessary.

4. Proper Labeling and Packaging

• The device must have appropriate labeling and packaging that complies with the requirements set out by the Department of Health (DH). This includes:

  • Manufacturer’s name and address.

  • Instructions for use (IFU).

  • Warnings and precautions.

  • Symbols and any regulatory marks (e.g., CE mark, UDI if applicable).

  • Labeling must be in English or Chinese (or both).

5. Risk Assessment and Safety Documentation

• A risk assessment must be performed to identify any potential hazards associated with the use of the device. Even though Class I devices are generally low risk, a basic risk analysis is required.

• The risk assessment should follow ISO 14971 guidelines, ensuring that the device's risk level is identified and managed.

6. Evidence of Safety and Performance

• You must demonstrate that the device meets the safety and performance requirements for its intended use. This includes providing evidence of:

  • Device performance data.

  • Clinical evidence (if required, though typically more relevant for higher-risk devices).

  • Bench testing or other performance testing (if applicable).

7. No History of Harmful Incidents

• If the device is already marketed in other regions (e.g., the EU, USA), there must be no history of serious incidents or safety concerns with the device.

• If the device is new to the market, there should be a documented plan for monitoring the device’s safety once in use.

8. Device Type and Intended Use

• The intended use of the device must align with the medical device definition in Hong Kong. Medical devices must be intended for use in:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.

  • Diagnosis, monitoring, treatment, or alleviation of injury or disability.

  • Pregnancy control or contraception.

Devices that are not intended for these purposes may not be eligible for MDACS registration as medical devices.

Where to Apply

• The application for Class I medical device MDACS registration must be submitted via the Medical Device Information System (MDIS) portal, which is the official online system for medical device registration in Hong Kong.

MDIS Portal: https://mdis.mdd.gov.hk

You must create an account on the MDIS portal to begin the registration process and submit all required documentation.

Conclusion

To apply for Class I medical device MDACS registration in Hong Kong, your device must meet the above criteria, including the correct classification, conformity with safety standards, proper labeling, and a risk assessment. You will also need to appoint an LRP if you are an overseas manufacturer and submit your application through the MDIS portal.

Ensure that all required documents are prepared in advance, and verify that your device complies with Hong Kong's regulatory requirements before submitting your application.

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