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Class C medical device MDACS registration in Hong Kong refers to the voluntary listing of a medium- to high-risk medical device under the Medical Device Administrative Control System (MDACS), which is overseen by the Medical Device Division (MDD) of the Department of Health, Hong Kong.
Although MDACS is not yet legally mandatory, it serves as the official framework for regulating medical devices in Hong Kong and is required by public healthcare institutions (e.g., Hospital Authority) for procurement. Therefore, obtaining MDACS registration is often essential for market access in Hong Kong.
🔷 What Is MDACS?
Full Name: Medical Device Administrative Control System
Established by: Medical Device Division (MDD), Department of Health
Purpose: To ensure that medical devices supplied in Hong Kong are of acceptable safety, quality, and performance
Current Status: Voluntary (but expected to be part of future statutory regulation)
Applicable Parties: Medical device manufacturers, importers, and Local Responsible Persons (LRPs)
🔷 What Is a Class C Medical Device?
Under MDACS (which aligns with the IMDRF/GHTF classification rules), Class C devices are those with:
Medium to high risk to patients and users
Typically invasive, active, or diagnostic in nature
🔸 Examples:
Infusion pumps
Patient monitors
X-ray and ultrasound machines
Surgical lasers
Invasive surgical devices (used short- or long-term)
Classification is based on Guidance Note GN-01, which uses criteria such as:
Duration of use
Invasiveness
Whether the device is active or implantable
Whether it supports or sustains life
🔷 What Does “Class C MDACS Registration” Mean?
Class C MDACS registration means:
✅ The Local Responsible Person (LRP) (on behalf of the manufacturer) has submitted a complete application to list the Class C device under MDACS.
✅ The application includes documentation proving:
The device has regulatory approval in a recognized reference market (e.g., CE/FDA/ARTG)
The manufacturer is compliant with ISO 13485
The device complies with Essential Principles of Safety and Performance (GN-03)
Clinical, technical, and performance documentation is adequate
✅ The application has been reviewed and approved by the Medical Device Division (MDD)
✅ The device has been officially listed in the MDACS database, and is assigned a Hong Kong Medical Device Number (HKMD No.)
🔷 Why Is Class C MDACS Registration Important?
| Reason | Explanation |
|---|---|
| ✅ Market Access | Required for supplying to public hospitals and for participating in tenders |
| ✅ Regulatory Credibility | Establishes the device as safe and effective in the local context |
| ✅ Risk Mitigation | Ensures device complies with safety standards, reducing liability |
| ✅ Preparation for Legal Regulation | Prepares stakeholders for the future legal framework that will replace MDACS |
🔷 Key Requirements for Class C MDACS Registration
| Requirement | Detail |
|---|---|
| LRP | A Hong Kong-based entity authorized to represent the manufacturer |
| Manufacturer registration | With ISO 13485 certificate (Form MD101) |
| Reference market approval | CE, FDA, ARTG, PMDA, or Health Canada |
| Technical dossier | Device details, performance data, risk analysis, labeling, etc. (GN-02, GN-03) |
| Listing form | Form MD102 for device registration |
| Submission format | Printed + electronic (USB or CD-ROM) |
| Post-market duties | Reporting, updating, vigilance (Form MD151 for adverse events) |
🔷 Summary: What It Means to Register a Class C Device Under MDACS
| Aspect | Description |
|---|---|
| Device Type | Medium to high risk |
| Listing Status | Voluntary (but practically necessary) |
| Legal Effect | Not yet statutory, but enforced for public sector procurement |
| Key Benefit | Enables market access in Hong Kong and adds regulatory credibility |
| Assigned Number | Hong Kong Medical Device Number (HKMD No.) after successful registration |
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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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