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What are the procedures, required materials, and important notes for handling Class A medical device registration under Hong Kong MDACS?
Release time：2025-05-14 14:07:07 The author: source:
Here’s a complete guide to the procedures, required materials, and important notes for handling Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS)

Here’s a complete guide to the procedures, required materials, and important notes for handling Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS):

✅ 1. PROCEDURES FOR CLASS A MEDICAL DEVICE REGISTRATION

Step-by-Step Workflow:

StepProcedure
1️⃣Confirm Device Classification: Ensure the device meets Class A criteria (low-risk, non-invasive, non-sterile, etc.).
2️⃣Appoint a Local Responsible Person (LRP): Required if the manufacturer is outside Hong Kong.
3️⃣Ensure LRP is Listed: Submit MD-LRP form if not already listed.
4️⃣Prepare Documentation: Collect and complete the required documents (see below).
5️⃣Submit Application: Submit the completed MD-TRF form and documents to the Medical Device Division (MDD).
6️⃣Wait for Review and Listing: MDD reviews the application; if accepted, the device is listed on the MDACS website.
7️⃣Post-Listing Compliance: Maintain device safety and report adverse events or changes through the LRP.

✅ 2. REQUIRED MATERIALS (DOCUMENTS)

📑 Mandatory Documents:

DocumentDescription
MD-TRF FormMedical Device Listing Application Form for Class A devices.
Device DescriptionProduct name, model number, intended use, physical description.
Justification of ClassificationExplain why the device qualifies as Class A under MDACS GN-01.
Labeling and IFUCopies of the packaging, product label, and Instructions for Use (in English or Chinese).
Manufacturer InformationName, address, and contact details of the original manufacturer.

📂 Recommended (Optional but Useful):

DocumentDescription
CE Declaration of ConformityProves compliance with EU safety and performance requirements.
FDA 510(k)/Premarket ApprovalDemonstrates U.S. market authorization (if applicable).
ISO 13485 CertificateShows manufacturer operates a certified QMS.

✅ 3. IMPORTANT NOTES

🔹 About MDACS:

  • Voluntary system as of 2025 (no mandatory regulation yet).

  • Some hospitals and procurement channels prefer or require MDACS-listed products.

🔹 Submission Method:

  • Submit by hand or post (no online application).

  • Address:

    Medical Device Division, Department of Health
    Room 3101, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong

🔹 Timeframe:

  • Approx. 1–3 months from submission to listing, depending on completeness and MDD workload.

🔹 Cost:

  • Free of charge for Class A devices (currently no fee for registration or review).

🔹 After Listing:

  • No certificate issued – only public listing on the MDACS website.

  • Maintain compliance through the LRP, including:

    • Reporting incidents and recalls

    • Updating the MDD if product information or manufacturer details change

🔹 Language Requirements:

  • All documents should be in English or Traditional Chinese.

  • Bilingual labeling is acceptable and encouraged.

✅ Summary Checklist

✔ Confirm device is Class A
✔ Appoint a registered Local Responsible Person
✔ Prepare MD-TRF and supporting documents
✔ Submit via post or in person to the Medical Device Division
✔ Monitor listing and ensure post-market obligations are met

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