Before applying for Class B medical device registration under the Hong Kong MDACS, thorough preparation is essential to ensure a smooth and efficient application process. Here’s a detailed list of key preparations you should undertake:

Preparations Before Applying for Class B Medical Device Registration under Hong Kong MDACS

1. Understand Device Classification

• Confirm your device is correctly classified as Class B according to MDACS classification rules.

• Review the classification guidelines on the Hong Kong Department of Health website.

2. Appoint a Local Responsible Person (LRP)

• Designate a Local Responsible Person in Hong Kong who will act as the liaison with the Medical Device Division (MDD).

• The LRP must have a local address and be authorized to represent the manufacturer.

3. Compile Technical Documentation

• Prepare complete technical documentation, including:

  • Device description and specifications

  • Risk management report (ISO 14971)

  • Safety and performance test reports

  • Labeling, packaging, and instructions for use (in English or Traditional Chinese)

  • Quality Management System certificate (ISO 13485)

  • Clinical data or equivalence evidence if applicable

4. Verify Compliance with Standards

• Ensure your device meets applicable international standards (e.g., IEC 60601, ISO 10993).

• Collect testing and certification reports to support compliance.

5. Prepare Regulatory Approvals from Other Markets

• Gather any relevant certifications or approvals from recognized regulatory authorities (e.g., CE Mark, FDA clearance).

6. Check Labeling and Packaging

• Ensure all labels and packaging materials comply with MDACS requirements.

• Translate materials into English or Traditional Chinese if needed.

7. Organize Application Documents

• Prepare all documents in the required format.

• Arrange documents clearly and logically to facilitate the review process.

8. Plan for Fees and Costs

• Budget for application fees, testing costs, consulting services (if any), and other related expenses.

9. Familiarize Yourself with the Submission Process

• Understand how to submit applications (usually by mail or in person to the Medical Device Division of the Department of Health).

• Review MDACS guidance notes and application forms.

10. Develop a Post-Market Plan

• Prepare a plan for post-market surveillance and vigilance to comply after registration.

Summary Checklist Before Application

Would you like me to help you prepare a detailed checklist or sample templates for any of these steps?

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