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To handle Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must meet specific regulatory, procedural, and documentation requirements. Below is a comprehensive guide to those requirements.
✅ 1. Device Classification Confirmation
➤ Requirement:
Determine and justify that the device is Class A (low risk), based on Guidance Notes GN-01.
✔️ Class A Device Characteristics:
Non-invasive
Non-sterile
Not measuring
Not reusable surgical instruments
Does not support or sustain life
🔸 Examples:
Manual wheelchairs
Bandages
Tongue depressors
Non-sterile gloves
Thermometers (non-electronic)
✅ 2. Appointment of a Local Responsible Person (LRP)
➤ Requirement:
If the manufacturer is located outside Hong Kong, they must appoint a Local Responsible Person (LRP) who is based in Hong Kong.
✔️ LRP Responsibilities:
Submit the application for device listing
Handle regulatory communication with the MDD
Report adverse events and maintain post-market surveillance
Ensure updates to product or manufacturer are notified
📌 LRP Must Be Registered:
The LRP must first be listed with the MDD using the MD-LRP application form before submitting device listings.
✅ 3. Documentary Requirements for Class A Device Listing
➤ Required Documents (based on Guidance Note GN-02):
| Document | Description |
|---|---|
| MD-TRF | Application form for listing a Class A device |
| Device Description | Product name, intended use, model numbers |
| Labeling and IFU | Package labeling and Instructions for Use (in English or Chinese) |
| Manufacturer Details | Company name, address, and contact |
| Classification Justification | Explanation why device qualifies as Class A |
| Evidence of Market Approval (optional but encouraged) | e.g., CE Declaration of Conformity, FDA clearance, ISO 13485 |
✅ 4. Submission of Application
➤ Method:
Submit by mail or in person to:
Medical Device Division
Department of Health
Room 3101, 31/F, Hopewell Centre,
183 Queen’s Road East, Wan Chai, Hong Kong
💰 Fee:
Currently no fee for Class A device listing
Subject to change if future mandatory regulation is enforced
✅ 5. Listing Outcome
If the application is complete and valid, the device will be listed on the MDACS website.
A Device Listing Number is assigned (no physical certificate is issued).
✅ 6. Post-Listing Obligations
✔️ Ongoing Requirements:
Incident Reporting: The LRP must report any adverse incidents or product recalls
Information Updates: Notify the MDD if there are changes to:
Manufacturer details
Product name/model
Device labeling
Maintain Technical Documentation for inspection upon request
📌 Summary Table
| Requirement Category | Details |
|---|---|
| Device Risk Class | Class A (Low Risk) |
| Regulatory Framework | MDACS – Voluntary (as of 2025) |
| Application Role | Local Responsible Person (LRP) must apply |
| Documentation | MD-TRF, device details, IFU/label, classification rationale |
| Submission Method | Physical (post or in-person) |
| Review Time | Around 1–3 months |
| Outcome | Device listing on MDACS website (publicly viewable) |
| Post-Market Duties | Vigilance, updates, and complaint handling |
| Cost | No fee currently |
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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