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What is the process, required documents, and key considerations for Class III medical device MDACS registration in Hong Kong?
Release time：2025-04-29 15:21:22 The author: source:
Here is a complete guide outlining the process, required documents, and key considerations for registering a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong:

Here is a complete guide outlining the process, required documents, and key considerations for registering a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong:

✅ 1. Registration Process for Class III Medical Devices

Step-by-Step Overview:

StepActionDetails
1️⃣Confirm classificationEnsure the device qualifies as Class III (high-risk) per MDACS.
2️⃣Appoint Local Responsible Person (LRP)The manufacturer must designate a Hong Kong-based entity (legal person) to act as the LRP.
3️⃣Compile documentsGather regulatory, technical, and quality documentation (see section below).
4️⃣Complete MDRR-1 FormUse the official MDRR-1 form.
5️⃣Submit applicationSend by email (preferred) or in-person to the Medical Device Division (MDD).
6️⃣Review by MDDMDD evaluates completeness and compliance; they may request clarifications.
7️⃣Device listingOnce approved, your device will appear on the “List of Medical Devices” on MDD’s website.

📄 2. Required Documents

DocumentDescription
MDRR-1 FormOfficial application form for device listing.
Device DescriptionSummary of the device, design, features, and intended use.
Classification JustificationExplain why the device qualifies as Class III.
Evidence of Reference Regulatory ApprovalApproval certificates from recognized authorities (e.g., CE, FDA, TGA, Health Canada).
Free Sale CertificateIssued by a competent authority confirming the device is legally marketed in that country.
Essential Technical Documentation (ETD)Includes labeling, instructions for use (IFU), safety info, manufacturing details, etc.
Clinical Evidence (if applicable)Especially for implantable or novel devices.
QMS Certificate (ISO 13485)Must be issued by an accredited certification body.
Post-Market Surveillance (PMS) PlanProcedures for vigilance, complaints, recalls, etc.
Images of Device and PackagingHigh-resolution photos of the product and packaging.
LRP Authorization LetterDeclaration by the manufacturer authorizing the LRP.
Business Registration of LRPValid Hong Kong business registration certificate.

⚠️ 3. Key Considerations

📌 Voluntary Nature:

  • MDACS is currently voluntary but widely adopted, especially in public tenders and hospital procurement.

📌 Local Responsible Person (LRP):

  • LRP must be based in Hong Kong and is legally responsible for:

    • Application submission,

    • Vigilance reporting,

    • Communication with MDD.

📌 Reference Regulatory Approvals:

  • Device must be approved in at least one recognized market, such as:

    • EU (CE under MDR)

    • US (FDA 510(k) or PMA)

    • Australia (TGA)

    • Canada (Health Canada)

    • Japan (PMDA/MHLW)

📌 No Official Fees:

  • As of now, MDACS does not charge for device registration.

📌 Typical Timeline:

  • 2–4 months for MDD review after submission, assuming documentation is complete and correct.

📬 Submission Details

  • By Email: mdd@dh.gov.hk

  • In Person / Post:
    Medical Device Division
    Department of Health
    Units 2-3, 13/F, Millennium City 6
    392 Kwun Tong Road, Kwun Tong, Kowloon, Hong Kong

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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