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For Class C medical devices registered under the Medical Device Administrative Control System (MDACS) in Hong Kong, although the listing has no fixed expiry date, the Local Responsible Person (LRP) and manufacturer are obligated to maintain the registration through regular updates, change notifications, and compliance monitoring. These updates ensure that the listed information remains accurate, traceable, and aligned with international standards.
Here is a detailed explanation of the standards and procedures for performing regular updates to a Class C medical device listing in MDACS.
✅ 1. Fundamental Principles
MDACS is a voluntary system, but:
It follows international best practices as recommended by the Global Harmonization Task Force (GHTF) and IMDRF.
All information must be kept current to ensure post-market safety and regulatory transparency.
Non-compliance or outdated information can result in suspension or de-listing.
📋 2. What Types of Updates Are Required?
| Type of Change | Requires Update to MDD? | Submission Requirement |
|---|---|---|
| Change in manufacturer’s name or address | ✅ Yes | Notify MDD with evidence |
| Change in device model, name, or intended use | ✅ Yes | Must submit updated technical documents |
| Change in labeling or IFU content | ✅ Yes | Provide revised labels and IFUs |
| Update to reference market approval (e.g., CE certificate renewal) | ✅ Yes | Submit new certificates |
| Change of Local Responsible Person (LRP) | ✅ Yes | Submit new Form MD100 and authorization |
| Minor editorial changes (e.g., artwork without content change) | ❌ No (in most cases) | May keep on record but not mandatory to submit |
| Software updates (for active devices) | ✅ Yes if impacting safety/performance | Submit validation records |
🧾 3. Procedures for Submitting Regular Updates
A. Identify the Type of Update
Determine whether the change affects:
Manufacturer identity
Device safety/performance
Clinical usage
Reference market validity
B. Prepare Supporting Documentation
Depending on the type of change, prepare the following:
Revised technical documents
Updated labeling and IFU
New CE/FDA certificate
Updated ISO 13485 certificate (if changed)
Revised Essential Principles Checklist (GN-03)
C. Prepare and Submit Update Package
Send a written notification letter signed by the LRP, including:
Summary of the changes
Justification
Affected document list
Revised documents (digital and printed)
📬 Submission Address:
Medical Device Division (MDD),
Department of Health,
Room 3101, 31/F, Hopewell Centre,
183 Queen's Road East, Wan Chai, Hong Kong
⏱ 4. Timeline for Notification
| Type of Update | When to Notify |
|---|---|
| Safety-related change | Immediately (within 10 days) |
| Major design or model change | As soon as change is finalized |
| LRP change | Before new LRP takes over |
| CE/FDA re-certification | Within 30 days of renewal |
🛠 5. Standards Supporting Regular Updates
MDACS expects updates to be in alignment with the following international standards:
| Standard | Purpose |
|---|---|
| ISO 13485:2016 | QMS and document control |
| ISO 14971:2019 | Risk-based change evaluation |
| IMDRF N68/2020 | Principles of medical device change management |
| IEC 62304 | Software update control |
| IEC 60601-1 (if applicable) | Re-validation for electrical safety |
| ISO 10993 series | Biocompatibility when material changes occur |
🧍 6. Role of the Local Responsible Person (LRP)
The LRP is legally responsible for:
Tracking changes from the manufacturer
Submitting timely updates to MDD
Ensuring all market-facing documentation in Hong Kong reflects current device status
Retaining documentation for at least 5 years
🛡 7. MDD Surveillance and Audit Rights
MDD may:
Audit the LRP or manufacturer to check if any unreported changes have occurred
Conduct random inspections or request updated files
Require updated labeling and technical files if a safety signal or complaint is received
🗂 8. Recommended Best Practices
| Practice | Benefit |
|---|---|
| Maintain a Regulatory Change Log | Tracks all changes affecting MDACS |
| Establish a Document Control SOP | Ensures consistent updates and record retention |
| Periodic internal audits (at least annually) | Catch unreported or undocumented changes |
| Monitor reference market certificates for expiry | Submit renewals before lapse |
| Communicate frequently with manufacturer’s regulatory team | Prevents delays in change reporting |
📌 Summary Table: MDACS Regular Update Procedures
| Step | Action |
|---|---|
| 1. Detect Change | Assess whether the update affects registration data |
| 2. Collect Documentation | Prepare revised IFUs, certificates, labels, etc. |
| 3. Notify MDD | Submit cover letter + updated documents |
| 4. Record Change | Log in internal regulatory file |
| 5. Await Acknowledgment | MDD may request clarification or accept silently |
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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