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What are the requirements for Class B medical device registration under the Hong Kong MDACS?
Release time：2025-05-16 15:30:02 The author: source:
To register a Class B medical device under the Hong Kong MDACS (Medical Device Administrative Control System), you must meet specific eligibility, documentation, and regulatory requirements set by the Medical Device Division (MDD) of the Hong Kong Department of Health.

To register a Class B medical device under the Hong Kong MDACS (Medical Device Administrative Control System), you must meet specific eligibility, documentation, and regulatory requirements set by the Medical Device Division (MDD) of the Hong Kong Department of Health.

Below is a comprehensive breakdown of the requirements:

✅ 1. Eligibility Requirements

📌 Product Scope:

  • The device must fall under Class B according to MDACS classification rules (based on IMDRF/GHTF principles).

  • Class B includes low-to-medium risk devices, such as:

    • Thermometers

    • Diagnostic ultrasound

    • Wound dressings (non-active)

    • Dental handpieces

📌 Regulatory Approval:

  • The product must already be approved or cleared in at least one of the recognized markets:

    • EU (CE under MDD or MDR)

    • USA (FDA 510(k), PMA)

    • Canada (Health Canada Licence)

    • Australia (TGA inclusion)

    • Japan (PMDA approval)

    • China (NMPA registration)

✅ 2. Applicant Requirement: Local Responsible Person (LRP)

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

    • A legal entity registered in Hong Kong.

    • Authorized in writing by the overseas manufacturer (if applicable).

  • The LRP is responsible for:

    • Submitting applications

    • Handling adverse event reporting

    • Acting as a local contact for the Department of Health

✅ 3. Document Requirements

📝 Application Form

  • Form MD001: Application form for device listing under MDACS.

📝 Supporting Documents Checklist:

DocumentDetails
Device DescriptionProduct name, model number(s), intended use, and classification rationale
Regulatory Approval CertificateCE certificate, FDA 510(k), or equivalent from recognized country
QMS CertificateISO 13485 certificate (issued by an accredited certification body)
Labeling & PackagingOuter labels, instructions for use (IFU), product brochures (in English/Chinese)
Risk Management SummarySummary compliant with ISO 14971
Clinical Evidence (if needed)Clinical evaluation report or published literature supporting safety/performance
Authorization Letter (if applicable)Letter from manufacturer authorizing the LRP

✅ 4. Technical Requirements

  • Your documentation must demonstrate that the device:

    • Meets recognized safety, performance, and labeling standards

    • Is manufactured under a certified QMS

    • Has undergone appropriate risk assessment and mitigation

✅ 5. Other Requirements

RequirementDetails
LanguageDocuments must be in English or Chinese
Application FormatPrinted hard copy submitted in person or by mail
No Application Fee (currently)The MDACS does not charge a listing fee
ComplianceMust comply with post-market vigilance, recalls, and updates

✅ 6. Post-Listing Responsibilities

Once your Class B device is listed:

  • Maintain current information in the MDACS system.

  • Report incidents or adverse events.

  • Notify the Department of Health of significant changes (design, model, label, etc.).

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