To apply for Class I medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), the following key requirements must be met:

1. Device Classification

• The device must be classified as Class I, which is the lowest risk category for medical devices under MDACS. These are typically non-invasive and simple devices with minimal risk to patients or users.

• You must confirm that your device falls under Class I based on the MDACS classification criteria, which are outlined in Technical Reference TR-003.

2. Appointment of a Local Responsible Person (LRP)

• If you are an overseas manufacturer, you must appoint a Local Responsible Person (LRP) in Hong Kong.

• The LRP acts as the local point of contact and is responsible for ensuring that the medical device complies with Hong Kong’s regulatory requirements. The LRP must be established in Hong Kong and registered with the Medical Device Division (MDD).

3. Registration on the MDIS Platform

• You must create an account on the MDIS (Medical Device Information System) platform to submit your application. This is the online portal for the registration of medical devices under MDACS.

• Access the platform here: MDIS Portal.

4. Required Documentation

You need to prepare and submit the following documents as part of your registration application:

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

• Manufacturing Information: Details about the device’s manufacturer, including the address and processes involved in manufacturing the device.

• Conformity to Safety and Performance Requirements: Evidence that the device complies with relevant safety and performance standards. This can be:

  • Declaration of Conformity to international standards (e.g., ISO 13485).

  • CE Mark certification or similar regulatory approvals (e.g., FDA clearance).

• Labeling Information: Details about the labeling of the device, including instructions for use, warnings, manufacturer’s name and address, and any relevant regulatory marks (e.g., CE or FDA mark).

• Risk Assessment: For Class I devices, the risk is usually minimal, but a basic risk assessment should be provided to support the classification.

5. Submission via MDIS Platform

• Once your documentation is ready, you need to submit your application via the MDIS platform. This includes:

  • Completing the online registration form with all device and manufacturer details.

  • Uploading the required documentation.

  • Paying any applicable registration fees (if applicable).

• After submission, the Medical Device Division (MDD) will review your application and all documents submitted.

6. Review and Approval

• The MDD will review the submitted application. They typically aim to process Class I medical device registrations within 12 weeks from the submission date, assuming all required documentation is correct and complete.

• If the device complies with the regulations and standards, the device will be listed under MDACS, and you will receive an official confirmation.

7. Ongoing Compliance

• After the device is listed, you must ensure continued compliance with MDACS regulations.

• You are responsible for updating device information if there are any changes (e.g., modifications to the device, manufacturer, or labeling).

• Post-market surveillance may be required, including reporting adverse events or handling recalls if necessary.

Key Points to Note:

• Class I devices are the lowest-risk devices, so the registration process is relatively straightforward compared to higher-risk classes.

• Voluntary Registration: MDACS registration is voluntary, but it helps demonstrate that the device meets Hong Kong’s safety and regulatory requirements, providing market confidence.

• Local Responsible Person (LRP) is essential if the manufacturer is outside of Hong Kong.

• Online Application: All registration steps are done through the MDIS platform, making it a centralized and digital process.

For more detailed instructions and access to the MDIS platform, you can visit the official MDACS page on the Hong Kong Department of Health’s website: MDACS - Department of Health, Hong Kong.

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