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The Medical Device Administrative Control System (MDACS) in Hong Kong requires that Class D medical device listings be maintained through periodic updates, especially as part of the listing renewal every 5 years, and whenever significant changes occur. These updates are crucial to ensure that the device continues to meet safety, performance, and regulatory requirements.
Below is a comprehensive explanation of the standards and procedures for periodic updates of Class D MDACS registrations, including renewals, variation updates, and post-market requirements.
🔷 1. Types of Periodic Updates
Periodic updates fall into three categories:
| Type | Description | Frequency |
|---|---|---|
| Renewal Update | Required every 5 years to maintain listing validity | Every 5 years |
| Variation/Change Notification | Triggered by changes in device, manufacturer, labeling, or QMS | As needed |
| Post-Market Surveillance Update | Ongoing updates related to adverse events, recalls, and performance | Continuous |
🔶 2. Standards Governing Periodic Updates
Hong Kong’s MDACS follows international principles established by the GHTF and IMDRF. The key applicable standards and guidance include:
| Standard/Guidance | Purpose |
|---|---|
| GN-01 / GN-02 | Essential principles compliance |
| GN-06 | Listing procedures for medical devices |
| GN-10 | Adverse event reporting and vigilance |
| GN-11 | Field safety corrective actions |
| ISO 13485:2016 | QMS requirements – clause 8 (monitoring, updating) |
| ISO 14971:2019 | Risk management – ongoing lifecycle updates |
| MEDDEV 2.7/1 Rev.4 / IMDRF Clinical Evaluation guidance | Clinical updates (if applicable) |
🔷 3. Listing Renewal Procedure (Every 5 Years)
📌 Steps:
Start the renewal process at least 6 months before listing expiry
Prepare a renewal application package that includes:
Completed renewal application form (via MDIS)
Updated Declaration of Conformity
Valid ISO 13485 certificate
Updated Essential Principles checklist (if standards changed)
Summary of post-market experience (complaints, AEs, recalls)
Payment of renewal fee (if applicable)
Submit through the Medical Device Information System (MDIS)
✅ Tip: If there have been no major changes, you may use a streamlined revalidation format.
🔷 4. Variation or Change Notification Procedure
If there are significant changes, a variation notification must be submitted immediately after the change. This includes:
🔹 Types of Reportable Changes:
| Category | Examples |
|---|---|
| Device design or performance | Changes in materials, sensors, algorithms, etc. |
| Indications for use | Expansion or narrowing of intended use |
| Labeling or IFU | New warnings, language changes, layout changes |
| Manufacturer details | Change in legal manufacturer, site, address |
| Regulatory status | Suspension/revocation of CE/FDA license |
| Sterilization or packaging | New sterilization method or packaging format |
| Software updates | Major version changes, cybersecurity patches |
📌 Steps:
Prepare a Change Notification Report:
Describe the nature of the change
Provide risk assessment and justification
Update technical documentation sections (e.g., risk file, labeling, clinical data)
Submit through MDIS with supporting documents:
Revised labeling or IFU
Updated technical documents
New test reports (if applicable)
Evidence of foreign market re-approval (if required)
Wait for MDD’s acknowledgment or further request. Do not implement changes in HK market until approved.
🔷 5. Post-Market Surveillance and Vigilance Update
Ongoing performance monitoring must be reported in specific formats:
| Activity | When Required | Submission Method |
|---|---|---|
| Adverse Event Report | Within 2/10/30 calendar days (per GN-10) | MDIS |
| FSCA Notification | Immediately upon action | MDIS + Field Safety Notice |
| Performance update | On request or during renewal | Email/MDIS |
| Annual complaint summary | Recommended for Class D | With renewal or inspection |
✅ Tip: Maintain an internal complaints and vigilance log, even if there are no incidents, for audit purposes.
🔷 6. Labeling and Packaging Updates
Labeling changes must be assessed based on their impact:
| Change Type | Action Required |
|---|---|
| Minor formatting | Record internally; no submission |
| Translation or language change | Notify MDD if affecting clarity or safety |
| Addition of new model/variant | Submit update with justification |
| Safety-related update | Immediate submission via MDIS |
🔷 7. Renewal and Update Review Timeline
| Type of Update | Approx. Processing Time |
|---|---|
| Renewal | 2–4 months (if no issues) |
| Variation / Change | 2–8 weeks (depending on complexity) |
| AE/FSCA Acknowledgment | 2–5 working days |
| Urgent safety actions | Priority handling by MDD |
✅ Summary: Periodic Update Workflow for Class D MDACS Devices
| Task | Frequency | Responsible Party |
|---|---|---|
| Listing renewal | Every 5 years | LRP / Manufacturer |
| QMS / ISO certificate renewal | Per ISO body schedule | Manufacturer |
| Adverse event reporting | Continuous | LRP |
| FSCA notification | Immediate | LRP |
| Technical document review | Annually (recommended) | QA/RA team |
| Change notification | As needed | LRP |
| Labeling/IFU updates | Before implementation | LRP |
📎 Best Practices
Track expiration dates of listing, ISO certificates, and overseas approvals
Use a regulatory calendar for 5-year renewal alerts
Maintain version control on all technical documents and labeling
Establish SOPs for change control and regulatory communication
Conduct internal audits at least once per year to prepare for MDD spot-checks
Would you like a template package including:
Listing Renewal Checklist (editable)
Change Notification Report Template
AE/FSCA Reporting Forms
I can generate and format these for your team based on your specific device type.
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