For Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the application must include specific materials and be prepared according to the standards set by the Medical Device Division (MDD) of the Department of Health. Here’s a breakdown of the necessary materials and guidance on preparing application documents:

Required Materials for Class I IVD Registration

1. Application Form (MD-IVD-1)

   • This is the primary form for Class I IVD device registration, available on the MDACS section of the Department of Health’s website. It requires details about the device, manufacturer, and intended use.

2. Technical Documentation

   • Device Description: Provide a clear, detailed description of the device, its design, specifications, intended purpose, and functions.
   • Labeling and Instructions for Use: Include actual labels, product packaging, and user instructions that explain how to use the device safely and effectively. These should address safety warnings, intended user groups, usage limitations, and storage instructions.
   • Risk Analysis and Management: Conduct a documented risk assessment, identifying any potential risks, control measures, and residual risks. This assessment should follow recognized standards such as ISO 14971.
   • Evidence of Safety and Performance: Include validation and performance testing reports, clinical evaluation data (if applicable), and other data that demonstrate the device’s safety and efficacy. If the device has been approved by other regulatory authorities, such as CE marking or FDA clearance, provide copies of these approvals to support the application.

3. Declaration of Conformity

   • This document is a signed statement by the manufacturer, declaring that the device conforms to applicable safety and performance standards required for Class I IVD devices.

4. Quality Management System (QMS) Documentation

   • ISO 13485 Certification (if available): While not mandatory for Class I devices, a QMS certification such as ISO 13485 demonstrates the manufacturer’s adherence to international quality standards and strengthens the application.
   • Quality Control Procedures: If a QMS certification is unavailable, include details about the manufacturer’s quality control practices, highlighting procedures that ensure consistent device quality.

5. Manufacturer Information

   • Manufacturer’s Details: Provide full contact information, including name, address, and a point of contact at the manufacturing site.
   • Authorized Representative (if applicable): If the manufacturer is based outside Hong Kong, appoint a local authorized representative and include their details. This representative will handle communications with the MDD on behalf of the manufacturer.

Steps to Prepare Application Documents

Step 1: Complete the MD-IVD-1 Application Form

• Fill in Device Information: Specify device name, model, intended use, and classification as Class I IVD.
• Manufacturer and Authorized Representative Details: Enter contact information for both the manufacturer and the authorized representative, if applicable.

Step 2: Assemble Technical Documentation

• Device Description: Create a comprehensive document that describes all aspects of the device, including its design, intended purpose, and technical specifications.
• Labeling and Instructions for Use: Gather all labeling and user instructions. Ensure these are accurate, clearly written, and consistent with the intended use described in the application form.
• Risk Assessment Documentation: Conduct a risk analysis and document it, identifying any hazards, risk mitigation measures, and residual risks. ISO 14971 guidelines provide a recognized framework for this documentation.
• Evidence of Safety and Performance: Compile data supporting device safety and efficacy. Include clinical data if available, and performance testing results that show the device meets safety and operational standards.

Step 3: Draft the Declaration of Conformity

• The Declaration of Conformity should be signed by an authorized individual from the manufacturing company. It confirms that the device meets all applicable standards for Class I IVD devices under MDACS.
• Include relevant international standards (e.g., ISO standards) or other regulatory requirements the device complies with.

Step 4: Prepare Quality Management System (QMS) Documentation

• If the manufacturer is ISO 13485 certified, attach a copy of the certification.
• If not, include a description of the manufacturer’s quality control processes. Outline quality assurance practices, including inspection, testing, and documentation procedures used to ensure device quality and consistency.

Step 5: Review and Organize All Materials

• Check for Completeness: Ensure that all required documents are included and that each document is complete, clearly labeled, and legible.
• Organize in Order: Arrange the documents according to the MDD’s requirements. Place the MD-IVD-1 application form first, followed by the technical documentation, Declaration of Conformity, QMS documentation, and any supporting evidence.

Step 6: Submit the Application

• Submit the completed application by mailing it to the MDD or delivering it to their office. Be sure to keep copies of all submitted documents for your records.

Important Considerations

• Document Consistency: Ensure all documents are consistent, especially details like the device name, model number, and intended use.
• Language Requirements: Prepare documents in English or Chinese, as these are the languages accepted by the MDD.
• Post-Market Compliance: After registration, monitor the device’s performance and report any adverse events to the MDD.
• Application Fees: Although Class I devices may have minimal or no fees, confirm with the MDD for the latest fee structure.

By preparing these materials thoroughly and following these steps, you can streamline the Class I IVD device registration process under Hong Kong’s MDACS.