The Class D medical device MDACS registration process in Hong Kong involves a structured pathway managed by the Medical Device Division (MDD) under the Department of Health (DoH). Class D devices are categorized as high-risk, including life-sustaining, implantable, or critical care devices such as pacemakers, dialysis systems, and heart valves.

Below is a comprehensive breakdown of the process, required documents, and key considerations:

🛠️ I. Registration Process for Class D Medical Devices under MDACS

🧩 1. Determine Device Classification

• Refer to:

  • TR-003 – Classification of General Medical Devices

  • TR-006 – Classification of In Vitro Diagnostic (IVD) Devices

• Class D includes:

  • Devices in contact with the central circulatory or nervous system

  • Devices used for life support or life-sustaining purposes

  • High-risk IVDs (e.g., HIV, blood grouping)

🧩 2. Appoint a Local Responsible Person (LRP)

• Required for all non-Hong Kong manufacturers.

• The LRP must:

  • Be a Hong Kong-registered business

  • Submit the application via MDIS

  • Maintain post-market compliance (vigilance, recalls, reporting)

🧩 3. Prepare and Compile Required Documentation

(See full list in Section II below)

🧩 4. Submit Application via MDIS (Medical Device Information System)

• Online-only submission as of April 2024

• MDIS link: https://www.mdd.gov.hk/en/mdacs/mdis/index.html

• Register an MDIS account under the LRP’s name

• Fill in product info, upload documents, and submit

🧩 5. Review by Medical Device Division (MDD)

• MDD will:

  • Validate completeness of submission

  • Review technical content and overseas certifications

  • Request additional documents if needed

• No fee is currently charged (MDACS is voluntary)

🧩 6. Listing and Issuance of Listing Certificate

• Upon successful review, MDD will issue:

  • Device listing number

  • Device listing on the MDACS official database

• Listing is valid for 5 years, renewable

📁 II. Required Documents for Class D MDACS Registration

🎯 III. Key Considerations for Class D MDACS Registration

✅ 1. GHTF Country Approval

• At least one prior approval from a recognized jurisdiction (EU, US, Australia, Japan, Canada, China, Korea, Singapore) is mandatory.

• Certificates must be current and valid.

✅ 2. LRP Responsibilities

• The LRP must:

  • Handle all communication with MDD

  • Respond to queries within deadlines

  • Submit vigilance reports (adverse events, recalls)

  • Maintain device traceability and update changes to labeling or design

✅ 3. Document Format

• Files must be uploaded through MDIS in PDF format.

• Labeling must be clear and in acceptable language(s).

• All certificates must be translated into English or Chinese if originally in another language.

✅ 4. Clinical Evaluation

• Mandatory for Class D devices

• Acceptable forms:

  • Peer-reviewed literature

  • Clinical investigation reports

  • Real-world evidence from recognized countries

✅ 5. Timelines

• Preparation of dossier: 1–3 months

• Review time: 3–9 months (depending on complexity and responsiveness)

• No official expedited route as of now

✅ 6. No Government Fee (as of now)

• MDACS is voluntary and does not currently require payment for registration.

• This may change when the Medical Device Ordinance becomes law.

🗂️ Summary Table

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