To apply for Class I medical device MDACS (Medical Device Administrative Control System) registration in Hong Kong, you need to follow a series of steps and apply through the appropriate platform. Here’s a detailed guide on how to apply and where to submit your application:

Steps to Apply for Class I Medical Device MDACS Registration in Hong Kong

1. Confirm Device Classification

   • Ensure that your medical device qualifies as Class I. Class I devices are generally low-risk and non-invasive, such as simple diagnostic tools or basic medical equipment.

   • You can verify your device classification by referring to TR-003, a document that outlines the classification criteria in Hong Kong.

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 submitting the registration and ensuring that your device complies with Hong Kong’s medical device regulations.

   • The LRP must be a Hong Kong-based entity and registered with the Department of Health (DH).

3. Create an Account on the MDIS Portal

   • MDIS Portal: All applications for MDACS registration must be submitted online through the Medical Device Information System (MDIS) portal.

   • Link to MDIS Portal: MDIS Registration Portal

   • You need to create an account on this portal if you do not have one already.

4. Prepare the Required Documents

   • Gather all the necessary documentation for your Class I device. This may include:

     • Device description and specifications.

     • Manufacturer details (and LRP if applicable).

     • Declaration of Conformity to relevant standards (e.g., ISO 13485, CE marking, or FDA clearance).

     • Product labeling and packaging information.

     • Risk assessment and safety documentation.

     • Local Responsible Person details if applicable.

5. Submit the Application Online

   • Complete the online application form via the MDIS portal.

   • Upload all the required documents and information, including:

     • The device description.

     • Conformity evidence (e.g., ISO certification or CE mark).

     • Labeling and packaging information.

     • Any other relevant compliance documents.

6. Pay the Registration Fee

   • For Class I devices, registration is typically free of charge in Hong Kong.

   • Ensure that you submit the application and follow any additional instructions provided by the MDIS system.

7. Review by the Department of Health (DH)

   • The Hong Kong Department of Health (DH) will review your application. If the documents and device meet all the requirements, your device will be registered under MDACS.

   • The review process for Class I devices generally takes around 12 weeks if all documents are complete and in order.

8. Approval and Listing

   • Once the review is complete, the Department of Health will approve the registration of your Class I device and list it in the MDACS system.

Where to Apply for Class I Medical Device MDACS Registration

• MDIS Portal: You will need to apply through the Medical Device Information System (MDIS) portal, which is the official platform for submitting medical device registration applications in Hong Kong.

• Website Link: MDIS Registration Portal

Once you access the MDIS portal, follow the instructions to create an account, submit your application, and track its status.

Conclusion

To apply for Class I medical device MDACS registration in Hong Kong, follow the outlined process of device classification, appointing a Local Responsible Person (if applicable), preparing the necessary documents, and submitting the application through the MDIS portal. Registration for Class I devices is relatively simple and fee-free, but ensuring you have all the necessary documentation and information is key to a successful application.

For more details, visit the MDIS portal: MDIS Registration Portal.

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