Before applying for Class B medical device MDACS registration in Hong Kong, thorough preparation is crucial to ensure a smooth and successful application process. Here’s a detailed checklist of key preparations:

🛠️ Preparations Before Applying for Class B MDACS Registration

1. Confirm Device Classification

• Verify that your device qualifies as Class B under MDACS rules.

• Refer to MDACS Classification Guidance (GN-06) or consult with the Hong Kong Medical Device Division (MDD) if unsure.

2. Appoint a Local Responsible Person (LRP)

• The LRP must be a Hong Kong-based entity or individual.

• They will act as your local regulatory contact and hold responsibility for compliance and communication with MDD.

3. Prepare Technical Documentation

• Compile the required technical file including:

  • Device description and intended use

  • Labeling and Instructions for Use (IFU)

  • Risk classification and risk management report (ISO 14971)

  • Quality Management System certificate (ISO 13485)

  • Reference market approval certificates (e.g., CE mark, FDA 510(k))

  • Declaration of Conformity

  • Device photos

• Ensure documents are in English or Chinese (certified translations if needed).

4. Verify Quality Management System (QMS)

• Ensure your manufacturing QMS complies with ISO 13485:2016.

• Obtain a valid certificate issued by a recognized certification body.

5. Obtain Reference Market Approvals

• Secure market clearance/certification from at least one recognized regulatory authority:

  • EU CE mark (MDR/MDD)

  • US FDA 510(k)/PMA

  • Australia TGA ARTG

  • Canada MDL

  • Japan PMDA

• These certificates are usually mandatory for MDACS registration.

6. Labeling and Packaging Compliance

• Prepare device labels and packaging consistent with MDACS requirements:

  • Include manufacturer name/address, device name/model, batch number, expiry date, warnings, and intended use.

  • Labels and IFU must be in English or Chinese.

7. Complete Forms and Fees

• Fill out Form MD1 (Device Listing Application) completely and accurately.

• Prepare payment for the application fee of HK$500 per device.

8. Prepare Appointment Letter for LRP

• Formal letter from manufacturer appointing the LRP.

• Signed and dated, outlining responsibilities.

9. Review and Organize Submission Package

• Organize all documents logically with a table of contents.

• Use tabs or dividers for easy reference.

• Make sure copies are clear and certified if required.

10. Plan Submission Method

• Decide how to submit: by postal mail or in-person to the Medical Device Division, Department of Health, Hong Kong.

✅ Summary Checklist

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