Here’s a clear step-by-step process for Class B medical device registration under MDACS in Hong Kong:

Step-by-Step Process for Class B Medical Device MDACS Registration

1. Confirm Device Classification

• Check that your device is classified as Class B under the MDACS classification rules.

2. Appoint a Local Responsible Person (LRP)

• Designate a Hong Kong-based LRP who will be your official regulatory contact for communications with the Medical Device Division (MDD).

3. Prepare Required Documents

• Collect all necessary documents including:

  • Completed Form MD1 (Device Listing Application)

  • Technical documentation (device description, labeling, IFU, risk management, QMS certificates, reference market approvals)

  • Copy of ISO 13485 certificate

  • Certificates from recognized markets (e.g., CE, FDA 510(k))

  • Appointment letter for LRP

  • Payment proof for application fee (HK$500 per device)

4. Submit Application Package

• Submit the complete application package to the Medical Device Division of the Department of Health by:

  • Mail: Address Medical Device Division, Department of Health, Hong Kong SAR

  • In-person: Direct submission at the Department of Health office

5. Application Fee Payment

• Pay the application fee of HK$500 per device when submitting the application.

6. Application Screening

• MDD performs an initial completeness check of the submitted documents.

• If the application is incomplete, MDD will request additional information.

7. Technical Review

• MDD reviews the technical documentation, risk assessment, and conformity to standards.

• Reference market approvals are verified.

8. Registration Approval

• If the review is satisfactory, MDD issues a device listing number for your Class B device.

• This allows legal marketing and distribution in Hong Kong.

9. Post-Registration Obligations

• Implement post-market surveillance.

• Report adverse events or changes using the appropriate forms.

• Maintain valid QMS and reference approvals.

10. Maintain Registration

• Update MDD promptly about any changes (manufacturer, labeling, intended use).

• Notify if discontinuing the product (delisting).

Summary Flowchart

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