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The MDACS (Medical Device Administrative Control System) in Hong Kong is a voluntary registration scheme overseen by the Medical Device Division (MDD) of the Department of Health. For Class B medical devices (low-to-medium risk), registration confirms compliance with international safety and performance standards.
✅ Procedures and Steps for Class B Medical Device Registration under MDACS
🔹 Step 1: Appoint a Local Responsible Person (LRP)
Who can apply? Only the Local Responsible Person (LRP) in Hong Kong can submit the device registration application.
The LRP must be:
A company or person based in Hong Kong
Registered with the MDD under Form MD-TR
Authorized by the manufacturer
📌 Foreign manufacturers must appoint a local LRP to apply on their behalf.
🔹 Step 2: Classify the Medical Device
Use MDACS classification rules (based on IMDRF/GHTF guidelines) to confirm the device is Class B.
Examples of Class B devices:
Thermometers
Low-risk surgical tools
Suction units
Infusion sets (non-critical use)
🔹 Step 3: Gather Supporting Documents
You need to compile a technical dossier and complete Form MD1 (Device Listing Application Form).
Required documents:
| Category | Description |
|---|---|
| Device Info | Description, intended use, model list |
| Labeling | Labels, IFU (in English/Chinese) |
| Manufacturer Info | Name, address, contact |
| Authorized LRP | Appointment letter, contact |
| Regulatory Approval | At least one of: CE (MDD/MDR), FDA 510(k)/PMA, TGA ARTG, Health Canada, Japan PMDA |
| QMS Certification | ISO 13485 certificate of the manufacturer |
| DoC | Declaration of Conformity signed by the manufacturer |
| Risk Info | Basic risk classification justification (if needed) |
If no prior approval is available, submit full technical documentation, including test reports and risk management files.
🔹 Step 4: Submit Application
Form MD1 + complete supporting documents must be printed and submitted in hard copy to:
Medical Device Division
14/F, Guardian House
32 Oi Kwan Road, Wan Chai
Hong Kong
Pay the application fee:
Typically HK$500 per application (subject to change)
🔹 Step 5: Review by MDD
The MDD reviews the application:
Checks conformity with MDACS requirements
May request additional information
Typical review period: 1–3 months
🔹 Step 6: Device Listing
If approved, the device is:
Listed in the “List of Medical Devices” on the MDD website
Assigned a Listing Number
Eligible for public sector procurement and recognized in Hong Kong
🔹 Step 7: Post-Market Obligations
The LRP must ensure:
Adverse event reporting
Recall coordination
Regulatory updates
Ongoing compliance with ISO 13485
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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