To apply for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must submit your application to the Hong Kong Department of Health (DH), which is responsible for the regulation of medical devices in Hong Kong.

Here’s a step-by-step guide on how to apply:

Where to Apply:

You will apply for Class IV medical device registration through the Hong Kong Department of Health’s Medical Device Division. The Department of Health oversees the MDACS (Medical Device Administrative Control System) and handles the application process for medical device registration.

Online Application:

1. Online Registration Platform:

   • The MDACS registration process for Class IV devices is primarily done online through the Department of Health's Medical Device Registration System (MDRS).

   • You will need to create an account and submit your application via this portal.

2. Website to Apply:

   • The MDACS official webpage is part of the Hong Kong Department of Health’s site:
     Department of Health - Medical Device Division

   • For the specific MDRS application, you will find the link and instructions for online submission on this page.

Steps to Apply for Class IV Medical Device Registration:

1. Register Online:

   • Create an account on the MDRS platform, which is provided by the Department of Health.

   • You will be required to register as a local responsible person (LRP) if you are not based in Hong Kong, or you can apply through a local distributor.

2. Complete the MD-APP Form:

   • Fill out the MD-APP Registration Form online, which requires:

     • Device details (name, description, intended use).

     • Manufacturer’s details.

     • Any certifications or approvals from reference markets (e.g., CE, FDA).

     • Clinical and performance data.

     • Quality management system certification (e.g., ISO 13485).

     • Device labeling and packaging information.

3. Prepare Required Documentation:

   • Ensure you have all required documents ready for upload. These include the Regulatory Approvals, Clinical Data, Risk Management Documentation, and Quality Management System Certification as discussed in previous messages.

4. Upload Documents:

   • Submit the required documents via the online portal. Ensure all documents are in English or Chinese and properly formatted (PDFs are usually accepted).

5. Pay the Application Fee:

   • Depending on the type and classification of the device, an application fee may apply.

   • You will need to pay the fee online as part of the submission process.

6. Submit the Application:

   • Once you have completed the form and uploaded all necessary documents, you can submit your application for Class IV medical device registration.

7. Review by the Department of Health:

   • After submission, the Department of Health will review the application.

   • They may request additional information or documentation, and you will be notified if any further details are required.

   • The processing time can vary based on the complexity of the device and the completeness of the documentation.

8. Approval or Rejection:

   • If your application is approved, the device will be registered under the MDACS and you will receive a registration certificate.

   • If rejected, you will be given an opportunity to address any issues raised before resubmitting.

Where to Get Help:

1. MDACS Helpdesk:

   • If you have questions during the registration process, you can contact the Medical Device Division of the Department of Health for assistance.

   • The contact details can be found on their official website.

2. Local Responsible Person (LRP):

   • If you're based outside Hong Kong, consider appointing a Local Responsible Person (LRP) who will act as your point of contact for the Department of Health.

Key Considerations for Application:

1. Timing: The approval process can take several months, depending on the completeness of your application and the complexity of the device.

2. Local Responsible Person (LRP): If you are a foreign manufacturer, appointing an LRP is a must. This person is legally responsible for ensuring that the device complies with Hong Kong regulations and can act as your liaison with the authorities.

3. Compliance with Standards: Ensure that the device meets the necessary international standards (ISO 13485, ISO 14971, etc.), as the Hong Kong regulatory authorities will look for evidence of compliance with recognized safety and quality standards.

4. Language: All documents submitted for registration must be in English or Chinese. Any documents in other languages must be translated by a certified translator.

Summary:

• Where: Apply through the Hong Kong Department of Health's MDRS.

• How: Complete the MD-APP form, upload documents, and submit online. Pay the application fee.

• Key Documents: Device description, clinical data, regulatory approvals, quality management system certificates, labeling information.

Would you like help with preparing any of these documents or more details on any part of the process?

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