To handle Class B medical device registration under the Hong Kong MDACS effectively, follow these key steps:

How to Handle Class B Medical Device Registration under Hong Kong MDACS

1. Understand the Regulatory Requirements

   • Confirm that your device falls under Class B according to Hong Kong’s medical device classification.

   • Familiarize yourself with MDACS regulations, guidelines, and requirements.

2. Appoint a Local Responsible Person (LRP)

   • Designate an LRP based in Hong Kong who will serve as the official liaison with the Medical Device Division (MDD).

   • The LRP handles communication, submission, and post-registration responsibilities.

3. Prepare Required Documentation

   • Gather and organize all necessary technical documentation:

     • Product description and intended use

     • Safety and performance data

     • Risk management files

     • Quality management system certificate (ISO 13485)

     • Labelling and instructions for use

   • Ensure documents comply with Hong Kong’s regulatory standards and language requirements.

4. Complete and Submit the Application

   • Fill out the official application form from the Hong Kong Department of Health.

   • Submit the application and supporting documents to the Medical Device Division, either by mail or in person.

   • Pay the applicable registration fee.

5. Follow Up During Review

   • Respond promptly to any requests for additional information or clarifications from MDD.

   • Maintain close communication through your LRP to ensure smooth processing.

6. Obtain Registration Confirmation

   • Once approved, receive your official registration number and confirmation.

   • Keep this documentation for regulatory compliance and marketing purposes.

7. Maintain Compliance Post-Registration

   • Implement post-market surveillance and report adverse events as required.

   • Notify MDD of any changes to the device, labeling, or manufacturing process.

   • Ensure continuous compliance with MDACS rules and standards.

Tips for Smooth Handling:

• Engage a regulatory consultant or experienced LRP if unfamiliar with Hong Kong regulations.

• Double-check all documentation for completeness before submission.

• Keep clear records and monitor regulatory updates from Hong Kong authorities.

If you want, I can help you draft the application or review your documents to avoid common pitfalls. Would you like assistance with that?

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