To apply for Class B medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), follow this step-by-step guide:

🩺 1. Understand MDACS and Class B Device Classification

• MDACS is a voluntary registration system managed by the Medical Device Division (MDD) of the Hong Kong Department of Health.

• Class B medical devices are considered low to medium risk.

• Devices are classified based on risk, in line with the IMDRF/GHTF classification rules.

📋 2. Eligibility to Apply

• The application must be submitted by a Local Responsible Person (LRP):

  • A registered company in Hong Kong.

  • Responsible for placing the device on the market.

  • Acts as the legal contact for the Department of Health.

🧾 3. Required Documents

The following are essential to support the application:

A. Basic Information

• Device name, model(s), intended use.

• Device classification and rationale.

B. Conformity Assessment Certificate

• One of the following:

  • EC Certificate under EU MDR/IVDR or MDD/IVDD (issued by Notified Body).

  • FDA 510(k) clearance or PMA approval.

  • Approval from Health Canada, Japan PMDA, Australia TGA, or China NMPA.

C. Quality System Certificate

• e.g., ISO 13485 certificate for the manufacturer.

D. Device Labeling and Instructions

• Labels, packaging, and Instructions for Use (IFU) in English (and/or Chinese).

E. Risk Management and Clinical Evidence

• Risk analysis per ISO 14971.

• Clinical data if applicable.

📬 4. Submission Process

1. Prepare Application Form:

   • Use Form MD001: “Application Form for Listing of Medical Devices.”

   • Available on the MDACS official website.

2. Submit via LRP:

   • Application must be submitted physically or by mail to the Medical Device Division (MDD).

   • Include all supporting documents and fees (if applicable).

⏳ 5. Review Timeline

• The review period for Class B device registration typically takes 3–6 months, depending on:

  • Completeness of documentation.

  • Device complexity.

  • Existing approvals from recognized authorities.

💵 6. Cost

• Currently, there is no government fee for listing under MDACS.

• However, you may incur:

  • Document preparation costs.

  • Third-party certification costs (e.g., ISO 13485, clinical evaluation).

  • Service fees if using a consultant or registration agent.

✅ 7. After Approval

• The device will be listed in the MDACS List of Medical Devices.

• The listing is voluntary, but it:

  • Enhances credibility.

  • May be required for public hospital procurement or tenders.

🔁 8. Maintenance

• MDACS listing does not expire, but:

  • Device information must be updated if there are changes.

  • Significant changes require a supplementary submission.

⚠️ 9. Key Notes

• MDACS is not a marketing authorization but a control system.

• Compliance with MDACS does not exempt a device from other Hong Kong laws (e.g., Import & Export Ordinance).

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