The Medical Device Administrative Control System (MDACS) in Hong Kong is a voluntary regulatory system designed to ensure the safety and performance of medical devices in the market. If you are looking to register a Class I medical device under MDACS, the following are the key steps and processes to follow:

1. Determine if the Device is Class I

Class I devices are low-risk medical devices, which are subject to minimal regulatory oversight. Before proceeding with the registration, ensure that your device qualifies as Class I based on the MDACS classification criteria. You can check the classification rules through Technical Reference TR-003. If unsure, you may also use the MDACS General Medical Device Classification Program available on the MDACS website.

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 will be responsible for ensuring that the device complies with all relevant regulations in Hong Kong, handling the registration process, and being the local contact for any regulatory matters regarding your device.

3. Register on the MDIS Platform

To begin the registration process, create an account on the Medical Device Information System (MDIS), which is the online platform for managing device listings and trader registrations in Hong Kong. The MDIS platform can be accessed through MDIS Portal.

4. Prepare Required Documentation

You need to gather and prepare the following documents for the application:

• Device Description: Information about the medical device, including its name, model, intended use, and design.

• Manufacturing Details: Information on where and how the device is manufactured.

• Conformity Assessment: Proof of compliance with essential safety and performance requirements. This can include certificates or declarations of conformity from international regulatory authorities (e.g., CE mark, FDA approval).

• Labelling Information: Ensure that your device labeling complies with Hong Kong regulations, including usage instructions, manufacturer details, and safety information.

• Risk Assessment: A simple risk analysis to demonstrate the low-risk nature of the Class I device.

5. Submit the Application via MDIS

Once you have registered on MDIS and prepared your documentation, you can submit your application for listing through the platform. You will need to:

• Log into your MDIS account.

• Complete the online form with the necessary details about your device.

• Upload the required documentation.

• Pay any applicable fees (if required) for the registration process.

6. MDACS Review

After submission, the Medical Device Division (MDD) of the Hong Kong Department of Health will review your application. They typically aim to process applications within 12 weeks from the submission date, provided all necessary documents are in order. The MDD may contact you for additional information if needed.

7. Approval and Listing

If your application is approved, your Class I medical device will be listed under MDACS. You will receive a confirmation, and the device will be officially registered in the system. This means your device is allowed to be marketed in Hong Kong.

8. Post-Listing Requirements

After the registration, you must ensure ongoing compliance with MDACS regulations. This may include:

• Updating device information if there are any changes to the device’s design or manufacturing.

• Ensuring that any post-market surveillance requirements are met.

• Reporting any adverse events or device recalls if applicable.

Key Considerations:

• Voluntary System: MDACS registration is voluntary, but having your device listed provides transparency and shows that your device meets the safety and performance requirements in Hong Kong.

• Local Responsible Person: An overseas manufacturer must have a Local Responsible Person (LRP) in Hong Kong to represent them in the registration process and communicate with the authorities.

• Online Submission: All applications and document submissions are done online through the MDIS platform, which simplifies the process.

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