Here’s a simple, step-by-step guide on how to register and apply for Class B medical device MDACS registration in Hong Kong:

How to Register and Apply for Class B Medical Device MDACS Registration

Step 1: Confirm Device Classification

• Make sure your device is classified as Class B under the MDACS framework.

Step 2: Appoint a Local Responsible Person (LRP)

• You need a representative based in Hong Kong who will be your official contact for the Department of Health.

Step 3: Prepare Your Application Package

• Complete Form MD1 (Application for Device Listing).

• Prepare required technical documents:

  • Device description and specifications

  • Labeling and Instructions for Use (IFU)

  • Risk management report

  • Quality Management System certificate (ISO 13485)

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

• Letter of appointment for your Local Responsible Person

• Proof of payment for the application fee (HK$500 per device)

Step 4: Submit Your Application

• Send your application package to the Medical Device Division (MDD) of the Department of Health in Hong Kong by mail or in person.

Step 5: Pay Application Fee

• Pay the fee of HK$500 per device and include proof of payment with your application.

Step 6: Undergo Application Screening

• MDD checks your submission for completeness.

• They may ask for additional information or clarifications.

Step 7: Technical Review

• MDD reviews the technical documentation for compliance with safety and quality requirements.

• Verification of foreign market approvals and quality management certificates.

Step 8: Respond to Requests

• If the MDD asks for more information or clarifications, respond promptly.

Step 9: Receive Registration Confirmation

• Once approved, the MDD will issue a device listing number.

• You are then authorized to sell your Class B medical device in Hong Kong.

Step 10: Maintain Compliance Post-Registration

• Conduct post-market surveillance.

• Report any adverse events or product changes.

• Notify MDD about updates or discontinuation of the device.

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