Class B medical device registration under Hong Kong’s MDACS refers to the voluntary listing of low‐to‐medium risk medical devices in the Medical Device Administrative Control System (MDACS), which is operated by the Medical Device Division of Hong Kong’s Department of Health.

1. What Is MDACS and Class B Registration?

• MDACS (Medical Device Administrative Control System)

  • A voluntary, non-mandatory listing scheme for medical devices placed on the Hong Kong market.

  • Aims to enhance post-market traceability and promote good regulatory practice.

  • Covers devices already approved or cleared by recognized overseas regulators.

• Device Classification

  • Follows IMDRF/GHTF risk‐based rules.

  • Class A: Low risk.

  • Class B: Low–medium risk (e.g., non‐invasive instruments that contact intact skin, diagnostic reagents).

  • Class C: Medium–high risk (e.g., invasive devices for short-term use).

  • Class D: High risk (e.g., implants, life-supporting devices).

• Why “Voluntary” Listing?

  • Not an approval or licence to market—manufacturers may already sell the device under other laws.

  • Listing builds confidence among hospitals, importers, and end users.

2. Who Can Apply?

• Local Responsible Person (LRP)

  • A company or organization registered in Hong Kong.

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

  • Takes responsibility for post-market vigilance and any corrective actions.

3. Key Benefits of Registering Class B Devices

1. Credibility

   • Demonstrates that your device has been reviewed against international standards.

2. Market Access

   • Preferred or required in public hospital tenders or procurement contracts.

3. Traceability

   • Facilitates recall management and adverse event reporting.

4. How to Apply: Step-by-Step

Step 1: Prepare Your Dossier

Your submission must include:

1. Application Form (MD001)

   • Download from the Department of Health website.

2. Device Overview

   • Trade name, model number(s), intended use, classification justification.

3. Conformity Evidence (choose one):

   • EC Certificate (EU MDR/MDD) issued by a Notified Body

   • FDA 510(k) clearance or PMA approval

   • Health Canada, Japan PMDA, Australia TGA, or China NMPA approval

4. Quality Management System Certificate

   • Usually ISO 13485:2016.

5. Labeling and Instructions for Use (IFU)

   • English (and/or Chinese) copies of labels, packaging, and user manuals.

6. Risk Management File

   • ISO 14971 risk analysis summary.

7. Clinical Evidence (if applicable)

   • Clinical evaluation report or literature review.

Step 2: Appoint a Local Responsible Person

• If you are an overseas manufacturer, nominate a Hong Kong–registered company to serve as your LRP.

• Provide a signed LRP letter of authorization.

Step 3: Submit Your Application

• By Mail or In Person to the Medical Device Division

• Include:

  • Completed MD001 form

  • All supporting documents (in clear, indexed order)

  • Proof of LRP appointment

Step 4: Departmental Review

• Initial Screening for completeness.

• Technical Review of conformity evidence and QMS.

• Queries may be raised—respond within specified timelines.

Step 5: Listing Outcome

• Approved Listings are published in the MDACS “List of Medical Devices.”

• No Listing Fee is currently charged by the government.

5. Timeline & Costs

• Review Time:

  • Typically 3–6 months from complete submission to listing.

  • Heavier review if additional technical or clinical data are requested.

• Costs:

  • Government listing: Free

  • Your out-of-pocket expenses:

    • Document translation & compilation

    • Third-party certificates (e.g., ISO 13485 audit, clinical evaluation)

    • Consultant or agent fees (if you engage one)

6. After Listing & Ongoing Maintenance

• No Expiry: Your listing remains valid indefinitely.

• Amendments: Submit a supplementary application for any significant changes (e.g., new models, labeling revisions).

• Vigilance: Report any field safety corrective actions or adverse events to the Department of Health.

⚠️ Key Takeaways

• MDACS Class B listing is voluntary but strategically valuable for market confidence.

• You must partner with an LRP in Hong Kong and provide recognized overseas conformity evidence.

• Assemble a complete technical dossier and plan for a 3–6-month review period.

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