To register and apply for Class B medical device registration under the Hong Kong MDACS, follow these key steps:

How to Register and Apply for Class B Medical Device Registration under Hong Kong MDACS

1. Confirm Device Classification

• Ensure your medical device is classified as Class B based on MDACS guidelines.

2. Appoint a Local Responsible Person (LRP)

• Designate an LRP who is based in Hong Kong to be your official regulatory contact.

3. Prepare Required Documentation

• Gather all necessary documents, including:

  • Completed application form (available from the Hong Kong Department of Health)

  • Product description, intended use, and specifications

  • Safety and performance test reports

  • Risk management documentation

  • Labelling and instructions for use (in English or Traditional Chinese)

  • ISO 13485 Quality Management System certificate

  • Any relevant regulatory certificates from other authorities

4. Submit Application

• Submit the application form and supporting documents to the Medical Device Division (MDD) by mail or in person.

5. Pay Registration Fees

• Pay the prescribed fees as outlined by MDACS.

• Retain payment proof for reference.

6. Application Review

• MDD reviews the submitted documents.

• They may request additional information or clarifications during the review process.

7. Receive Registration Certificate

• Upon approval, you will be issued a registration confirmation and number.

8. Post-Registration Compliance

• Conduct post-market surveillance.

• Report any adverse events or product changes to the MDD.

• Renew registration as required.

If you want, I can assist you with preparing the documents or help clarify any step in the application process. Would you like help with that?

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