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How to apply for Class D medical device MDACS registration in Hong Kong?
Release time：2025-07-08 15:41:23 The author: source:
Applying for Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) is a voluntary process managed by the Medical Device Division (MDD) of the Department of Health (DoH). Class D represents the highest risk category (e.g. implantable devices, life-supporting equipment, HIV test kits, etc.), and thus requires the most stringent documentation and regulatory compliance.

Applying for Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) is a voluntary process managed by the Medical Device Division (MDD) of the Department of Health (DoH). Class D represents the highest risk category (e.g. implantable devices, life-supporting equipment, HIV test kits, etc.), and thus requires the most stringent documentation and regulatory compliance.

✅ Step-by-Step Guide: How to Apply for Class D Medical Device MDACS Registration in Hong Kong

🔷 Step 1: Confirm the Device Classification

Use the official classification guidance:

  • GN-01: For general medical devices

  • GN-02: For in vitro diagnostic (IVD) medical devices

🔎 Class D includes:

  • Life-sustaining or life-supporting devices (e.g. pacemakers)

  • Implantables (e.g. orthopedic implants)

  • IVDs used to detect transmissible diseases (e.g. HIV, HBV)

📌 Tip: Prepare a written classification rationale and keep for submission.

🔷 Step 2: Appoint a Local Responsible Person (LRP)

Only a Local Responsible Person (LRP) can submit an application to MDACS.

LRP must:

  • Be a Hong Kong-registered company

  • Have technical and regulatory capacity to:

    • Maintain the technical documentation

    • Submit and manage the application via MDIS

    • Handle post-market obligations (vigilance, FSCA, recalls)

📌 Required documentation:

  • LRP registration form

  • Business Registration Certificate

  • Manufacturer Authorization Letter (MAL)

🔷 Step 3: Prepare the Technical File and Application Documents

Prepare the required documents according to MDACS standards and GHTF/IMDRF guidelines.

Essential documents include:

CategoryExample Documents
Manufacturer InformationISO 13485 certificate, company profile
Regulatory ApprovalCE certificate (MDR), FDA 510(k)/PMA, TGA, etc.
Risk ManagementISO 14971-compliant Risk Management File
Clinical EvaluationClinical Evaluation Report (CER) or literature review
Performance TestingElectrical, biocompatibility, EMC, software validation
Labeling & IFUIn English and/or Traditional Chinese
Declaration of ConformitySigned by manufacturer
Essential Principles ChecklistBased on GN-01 or GN-02
Post-Market Surveillance PlanAE handling, complaint SOPs, FSCA procedure

🔷 Step 4: Register on MDIS (Medical Device Information System)

All submissions are done through the online portal:

👉 MDIS Website: https://mdis.mdco.gov.hk

Steps:

  1. LRP registers and logs into the MDIS portal

  2. Select “Apply for Listing of Medical Device”

  3. Fill out the online form (device information, overseas approval, manufacturing site, etc.)

  4. Upload supporting documents in PDF format

  5. Submit electronically

📌 No physical submission is needed.

🔷 Step 5: MDD Review Process

After submission:

  • Administrative Review: MDD checks for completeness (2–4 weeks)

  • Technical Review: Detailed assessment of compliance with safety, performance, and essential principles (3–6 months)

  • Clarification Requests: MDD may request additional data, explanations, or updated files

📌 You must respond to clarification requests typically within 10–30 calendar days.

🔷 Step 6: Device Listing and Registration Confirmation

If the application passes all checks:

  • MDD issues a Letter of Acceptance

  • Device is added to the List of Medical Devices on the MDACS website

  • A unique Listing Number (e.g., MDXXXXXX) is assigned

📌 Listing is valid for 5 years and must be renewed before expiry.

🧾 Summary of Required Documents

DocumentRequired for
ISO 13485 CertificateQMS compliance
CE/FDA/TGA CertificateRegulatory recognition
Manufacturer Authorization LetterLRP appointment
Technical DossierRisk, clinical, performance, labeling
Declaration of ConformityManufacturer accountability
Essential Principles ChecklistDemonstrating compliance
Post-Market Surveillance SOPVigilance and FSCA readiness
Labeling & IFULanguage and safety info

⏳ Estimated Timeline

StageTime
Pre-application preparation1–3 months
MDACS submission review3–6 months
Clarification rounds1–2 months (if needed)
Final approval and listing1–2 weeks

👉 Total estimated time: 4–9 months
👉 Faster if submission is complete and compliant from the start.

✅ Important Considerations

ItemNote
Application FeeCurrently free (subject to change)
LanguageDocuments must be in English and/or Traditional Chinese
Post-Market ObligationsAEs, recalls, renewals, and changes must be reported
RenewalsRequired every 5 years
Listing StatusVoluntary, but often required for public tenders and hospitals

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