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After submitting your Class C medical device registration application under Hong Kong’s Medical Device Administrative Control System (MDACS), both the manufacturer and the Local Responsible Person (LRP) must follow several regulations and ongoing requirements to maintain compliance during the review period and afterward (if registration is granted).
Below is a detailed breakdown of the post-application regulatory obligations and best practices to observe under the MDACS framework:
✅ 1. Maintain Up-to-Date Submission During Review
Even after submission, the Medical Device Division (MDD) may request updates. Therefore, the applicant must:
| Requirement | Description |
|---|---|
| 📄 Timely Response to Queries | MDD may request clarifications or additional documents—respond within the deadline (typically 2–4 weeks) |
| 🧾 Submit Additional Evidence | If MDD finds gaps in clinical data, safety info, or labeling, you must provide supporting materials |
| 📢 Notify of Major Changes | If the manufacturer, device model, labeling, or reference market approval changes during the review, you must inform MDD immediately |
✅ 2. Comply with the Essential Principles (GN-03)
The device must continue to comply with the Essential Principles of Safety and Performance.
📎 These include:
Biocompatibility
Electrical and mechanical safety
Performance under intended conditions
Risk management per ISO 14971
Software validation (if applicable)
If changes occur to the device that impact these principles, the applicant may need to submit a revised technical dossier or restart the process.
✅ 3. Maintain Reference Market Approvals
MDD accepts registration only for devices approved in at least one reference market (e.g., CE, FDA, TGA, PMDA).
During and after submission:
Ensure reference market approvals remain valid and active
If CE or FDA clearance is suspended, revoked, or expired, notify MDD immediately
If new approvals (e.g., Canadian MDL or Japanese Shonin) are obtained, these may strengthen your application
✅ 4. Keep LRP Status Active and Valid
Your application depends on a valid Local Responsible Person (LRP). Therefore:
| Requirement | Description |
|---|---|
| 🧾 Maintain LRP’s company registration in Hong Kong | |
| 📄 Ensure authorization letter from the manufacturer is current | |
| 🧍 The LRP must be prepared to assume post-market responsibilities as soon as the device is approved |
If your LRP changes during the application, you must re-submit Form MD100 and authorization documents.
✅ 5. Ensure Labeling and Instructions for Use Remain Valid
Even after submission:
Labeling and Instructions for Use (IFU) must remain accurate and up-to-date
Language must remain in English or Chinese
Any revision in artwork, model number, claims, or indications should be reported
If MDD identifies inconsistencies, the registration may be delayed or denied.
✅ 6. Prepare for Post-Market Obligations (Once Registered)
Once registration is granted, you will be expected to comply immediately with:
| Obligation | Description |
|---|---|
| 🛡️ Adverse Event Reporting | Must report serious incidents using Form MD151 |
| 📢 Field Safety Corrective Action (FSCA) | Notify MDD of recalls, software corrections, safety notices issued in other countries |
| 🧾 Post-Market Surveillance | Monitor customer complaints, safety trends, and performance |
| 🔁 Change Notification | Notify MDD of changes to device specs, manufacturer, LRP, or reference market approval |
| 📁 Record Retention | Maintain records of import, complaints, distribution, and traceability for at least 5 years |
✅ 7. Allow MDD to Inspect if Necessary
Although MDACS is voluntary, the Medical Device Division (MDD) reserves the right to:
Audit the Local Responsible Person
Request samples for evaluation
Verify technical documents or labeling
Investigate complaints or adverse events reported locally
📌 Summary: Key Post-Application Requirements
| Area | Obligation |
|---|---|
| 🧾 Submission Updates | Respond promptly to queries, update data if needed |
| 🌍 Reference Market | Maintain CE/FDA/TGA/PMDA approval throughout process |
| 👤 LRP | Must be active, authorized, and capable of post-market duties |
| 🏷️ Labeling | Must remain accurate and compliant in English/Chinese |
| 🛡️ Safety Surveillance | Prepare for post-market reporting upon registration |
| 🏢 Inspections | MDD may request documentation or conduct audits |
🔧 Recommended Preparations While Waiting for Approval
| Action | Purpose |
|---|---|
| ✅ Set up complaint handling SOPs | Required post-market |
| ✅ Train LRP staff on FSCA and reporting | Essential for adverse event compliance |
| ✅ Prepare internal PMS forms | Useful upon approval |
| ✅ Plan for commercial launch only after listing is confirmed | Avoid premature marketing |
Would you like:
A regulatory compliance checklist for Class C devices during and after MDACS application?
Sample templates for post-market surveillance, FSCA reports, or adverse event reports?
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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