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Class A Medical Device Registration under Hong Kong MDACS: Process & Procedure
The Medical Device Administrative Control System (MDACS) is a voluntary regulatory system implemented by the Medical Device Division (MDD) of the Hong Kong Department of Health to monitor the safety and quality of medical devices marketed in Hong Kong. Class A devices are considered low-risk and follow a streamlined registration process compared to higher-risk classes (B–D).
🔹 Step-by-Step Process for Class A Medical Device Registration
✅ Step 1: Confirm Classification of the Device
Under MDACS Guidance Note GN-01, devices are classified based on risk.
Class A devices are non-invasive, non-sterile, non-measuring, and not reusable surgical instruments.
Examples:
Tongue depressors
Cotton swabs
Non-sterile gloves
Bandages
Manual wheelchairs (non-powered)
✅ Step 2: Appoint a Local Responsible Person (LRP)
If the manufacturer is not based in Hong Kong, a Local Responsible Person must be designated.
The LRP is responsible for:
Submitting the registration
Liaising with the MDD
Handling post-market surveillance
Note: The LRP must first be listed under MDACS using the Local Responsible Person Listing Form (MD-LRP).
✅ Step 3: Prepare Registration Documents
The required documentation is outlined in Guidance Note GN-02.
For Class A medical devices, the basic documents include:
| Document | Description |
|---|---|
| 📄 MD-TRF Form | Completed Device Listing Application Form (for Class A devices) |
| 🏷️ Device Description | Product name, intended use, model number, classification rationale |
| 📦 Labeling & IFU | Packaging, product label, and Instructions for Use (IFU) |
| 🏭 Manufacturer Info | Name, address, and contact information of the original manufacturer |
| 📃 Evidence of Compliance (Optional but recommended) | CE Declaration of Conformity, FDA 510(k), ISO 13485, etc. |
| 📑 Risk Classification Justification | Explanation of why the device qualifies as Class A |
✅ Step 4: Submit the Application to MDD
The Local Responsible Person submits the application on behalf of the manufacturer.
Submit the documents by hand or post to the Medical Device Division of the Department of Health.
Submission address:
Medical Device Division
Department of Health
Room 3101, 31/F, Hopewell Centre,
183 Queen’s Road East, Wan Chai, Hong Kong
As of now, electronic submission is not officially implemented, though this may change in the future.
✅ Step 5: Application Review by MDD
The MDD will evaluate the application and may request clarifications or additional documents.
If the submission meets requirements, the device will be listed on the MDACS website.
There is no certificate issued, but a Device Listing Number is assigned and shown publicly online.
✅ Step 6: Maintain Compliance
Once listed:
The LRP is responsible for post-market surveillance.
Report adverse events or recalls to the MDD.
Inform MDD of changes to the product, manufacturer, or labeling.
📌 Summary Table
| Item | Description |
|---|---|
| Regulation System | MDACS (Medical Device Administrative Control System) |
| Regulator | Medical Device Division (MDD), Department of Health, Hong Kong |
| Device Class | Class A – Low Risk |
| Registration Type | Voluntary Listing |
| Who Can Apply | Local Responsible Person (LRP) on behalf of the manufacturer |
| Application Form | MD-TRF (Device Listing Form for Class A) |
| Submission Method | Physical (in-person or mail) |
| Review Time | Typically 1–3 months |
| Certificate Issued | No; only listing on MDACS website |
| Post-Market Duties | Vigilance, incident reporting, update product information via the LRP |
| Fee | Currently free for Class A device registration (subject to change) |
🔍 Notes
MDACS is not mandatory yet, but many hospitals, distributors, and procurement tenders require MDACS-listed products.
Having overseas certifications (CE, FDA, ISO 13485) simplifies registration and enhances acceptance.
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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