Here's a clear overview of the process and steps for Class B medical device registration under the Hong Kong MDACS:

Process and Steps for Class B Medical Device Registration under Hong Kong MDACS

Step 1: Confirm Device Classification

• Verify that your medical device is classified as Class B under Hong Kong MDACS guidelines.

• Classification is based on risk and intended use.

Step 2: Appoint a Local Responsible Person (LRP)

• Designate a Local Responsible Person with a registered address in Hong Kong.

• The LRP acts as the official contact with the Medical Device Division (MDD).

Step 3: Prepare Application Documents

• Compile necessary technical documentation, including:

  • Product description and specifications

  • Risk analysis and management report

  • Safety and performance test reports

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

  • Quality management system certificate (ISO 13485)

  • Certificates from other regulatory bodies (if applicable)

Step 4: Complete the Application Form

• Obtain the official application form from the Hong Kong Department of Health website or Medical Device Division.

• Fill in all required details accurately.

Step 5: Submit Application

• Submit the completed application form along with all supporting documents to the Medical Device Division.

• Submission can typically be done via:

  • Mail

  • In person at the Department of Health office

Step 6: Pay Application Fees

• Pay the prescribed registration fee.

• Keep the payment receipt as proof.

Step 7: Application Review

• The Medical Device Division reviews the submission for completeness and compliance.

• They may request additional information or clarification.

Step 8: Approval and Registration

• Once approved, the device is registered under MDACS.

• You will receive a confirmation and registration number.

Step 9: Post-Registration Obligations

• Implement post-market surveillance.

• Notify MDD of any changes or adverse events.

• Maintain compliance with labeling, quality, and reporting requirements.

Summary of Steps

If you want, I can help you draft the application form or review your documents before submission. Would you like assistance with that?

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