For Class I medical device MDACS registration in Hong Kong, the technical documentation required must demonstrate that the device meets the relevant safety, performance, and regulatory requirements. The Department of Health (DH) assesses this documentation to ensure compliance with Hong Kong's medical device regulations.

Technical Document Requirements for Class I Medical Device MDACS Registration in Hong Kong

Here’s a list of the typical technical document requirements for Class I medical devices:

1. Device Description and Specifications

• A detailed description of the device, including:

  • Intended use and indications.

  • Functional description.

  • Mode of action (how the device works).

  • Device materials and components (e.g., materials used in construction).

  • Size, model, and variations (if applicable).

• Product specifications outlining key characteristics, dimensions, and features.

2. Manufacturer Details

• The name and address of the manufacturer.

• If the manufacturer is based outside Hong Kong, the Local Responsible Person (LRP)’s details must also be provided.

• If applicable, authorization letters from the manufacturer granting the LRP permission to submit the registration on their behalf.

3. Conformity Evidence

• Evidence of conformity with relevant international standards and regulations. This may include:

  • ISO 13485 certification for Quality Management Systems (QMS), especially for manufacturers.

  • ISO 14971 (Risk management for medical devices).

  • CE marking, FDA clearance, or other international certifications (if applicable).

• Declaration of Conformity for the device, stating that it meets applicable safety and regulatory standards.

4. Labeling and Packaging Information

• Device labeling, including:

  • Manufacturer’s name and contact details.

  • Instructions for use (IFU).

  • Warnings and precautions.

  • Symbols and regulatory marks (e.g., CE mark or ISO standards).

• Packaging details, including:

  • Information about packaging and sterilization (if applicable).

  • Storage and transportation conditions.

  • Any relevant shelf-life information (for devices with expiry dates).

5. Risk Assessment

• A risk assessment in line with ISO 14971 that identifies potential risks associated with the device's use.

  • This may include:

    • Hazard identification.

    • Risk estimation.

    • Risk control measures (mitigation plans for identified risks).

  • For Class I devices, this typically involves a simpler risk assessment, but it still ensures that the device poses minimal risk to users or patients.

6. Clinical Data (if applicable)

• While Class I devices are low-risk and typically do not require clinical trials, you must provide clinical data if necessary (for example, if the device claims therapeutic effects).

• Clinical evidence might be required if the device makes medical claims or if it is intended for specific patient populations that require further evaluation.

7. Declaration of Conformity

• The Declaration of Conformity affirms that the device complies with the relevant standards and regulations, such as CE Marking, ISO 13485, and other applicable international standards.

• This document ensures that the device meets the essential safety and performance requirements in Hong Kong.

8. Quality Management System (QMS) Documents

• If the manufacturer is required to follow a Quality Management System (QMS), provide evidence of its implementation.

• The ISO 13485 certification serves as the primary evidence for QMS adherence.

• Other supporting documents, such as quality control processes, may also be required.

9. Safety and Performance Data

• Provide safety and performance data demonstrating that the device performs as intended and does not pose any undue risks to users.

• This could include bench testing, electrical safety testing, or other relevant performance evaluations.

10. Post-market Surveillance Plan (if applicable)

• For certain Class I devices that may require post-market monitoring, provide a post-market surveillance plan that outlines how the safety and performance of the device will be monitored after it is placed on the market.

11. Other Supporting Documents (if applicable)

• Any other relevant documents, such as:

  • Importation certificates if the device is imported from another country.

  • Country-of-origin documentation.

  • Certificates of Free Sale if the device is already marketed in another jurisdiction.

How to Prepare These Documents

• Ensure Compliance with Hong Kong Regulations: Make sure that your technical documents meet the specific regulatory requirements outlined by the Hong Kong Department of Health (DH).

• Accurate and Clear Information: Provide clear, accurate, and detailed information in each of the required documents. For example, labeling must be precise, and risk assessment should thoroughly address any potential risks.

• Engage Local Responsible Person (LRP): If applicable, work with your LRP to ensure that all documents are prepared in accordance with Hong Kong’s specific requirements.

Conclusion

When applying for Class I medical device MDACS registration in Hong Kong, the technical documentation is crucial for ensuring that your device complies with local regulations. The documents you need to prepare include device specifications, manufacturer details, conformity evidence, risk assessments, labeling information, and other supporting documents. Make sure to work closely with your Local Responsible Person (LRP) if you are an overseas manufacturer to submit accurate and complete documentation for a smooth registration process.

For more detailed guidance, always refer to the official Hong Kong Department of Health regulations or the MDIS portal.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn