In Hong Kong, the Medical Device Administrative Control System (MDACS) provides a voluntary framework for the listing of medical devices, including Class I general medical devices. Class I devices are considered low-risk and are subject to less stringent regulatory controls. The MDACS aims to ensure the safety and performance of medical devices available in the market.

✅ How to Apply for Class I Medical Device Listing under MDACS

1. Determine Device Classification
   Classify your device according to the MDACS classification rules. Class I devices are low-risk and are subject to less stringent regulatory controls. The classification rules are outlined in Technical Reference TR-003. You can use the MDACS General Medical Device Classification Program to assist in determining the appropriate classification.

2. Appoint a Local Responsible Person (LRP)
   If you are an overseas manufacturer, you must appoint a Local Responsible Person (LRP) in Hong Kong. The LRP is responsible for ensuring that the device complies with local regulatory requirements and for submitting the listing application on your behalf.

3. Register on the MDIS Platform
   Create an account on the MDIS portal at https://mdis.mdd.gov.hk. This platform facilitates the submission of online applications for device listings and trader registrations under MDACS.

4. Prepare Required Documentation
   Ensure that all necessary documents are ready for submission, which may include:

   • Device description and intended use

   • Manufacturing details

   • Conformity with essential safety and performance principles

   • Labelling information

5. Submit the Application
   Complete and submit the application form for the listing of Class I general medical devices through the MDIS platform. The application will be reviewed, and you will receive an acknowledgment email within approximately two weeks. If you do not receive this acknowledgment, contact the Medical Device Division to confirm receipt of your application.

6. Await Approval
   The Medical Device Division aims to process applications within 12 weeks after receiving all required documentation. Upon approval, your device will be listed under MDACS, and you will be notified accordingly.

📄 Additional Resources

• Guidance Notes: Refer to the Guidance Notes for Definitions and Abbreviations (GN-00) and the Overview of the Medical Device Administrative Control System (GN-01) for detailed information on the MDACS framework.

• Classification Rules: Consult Technical Reference TR-003 for the classification rules applicable to general medical devices.

• Online Tools: Utilize the MDACS online tools to assist in determining your device's classification and to access the MDIS portal.

For further assistance or specific inquiries, you can contact the Medical Device Division directly through the contact information provided on their official website.

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