After obtaining Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), it’s essential to maintain compliance and fulfill your post-market responsibilities. The Medical Device Division (MDD) of the Department of Health expects the Local Responsible Person (LRP) and manufacturer to proactively manage the product throughout its life cycle in the Hong Kong market.

✅ Key Points to Note After Obtaining Class C MDACS Registration

🔹 1. No Expiry Date, But Ongoing Responsibility

MDACS registration does not have an official expiry date, but:

• The LRP must maintain up-to-date documentation

• Any significant changes must be reported to MDD

• The product must continue to meet all safety and performance standards

🔹 2. Post-Market Surveillance (PMS) Obligations

The LRP is legally responsible for post-market activities, including:

🛡️ A. Adverse Event Reporting

• Mandatory reporting of serious incidents involving the device

• Use Form MD151

• Submit to MDD within 10 calendar days of awareness

📉 B. Device Defect Reporting

• Report any known defects or risks of harm

• Include field safety notices, recalls, or corrections

📬 C. Field Safety Corrective Actions (FSCA)

• If taken overseas, these actions must also be reported in Hong Kong

• Submit supporting documents (e.g., recall notices, letters to users)

🔹 3. Notification of Changes to Registered Information

You must notify the MDD in writing if any of the following changes occur:

⚠️ Failure to notify may lead to delisting.

🔹 4. Compliance Maintenance

🔍 A. Ensure Device Consistency

• Imported and sold devices must match what was registered

• MDD may inspect or audit samples to verify compliance

📁 B. Document Retention

• Keep technical documentation and related records for at least 5 years

• MDD may request access during investigations or audits

🧾 C. Batch/lot traceability

• LRP must maintain batch records and sales logs

🔹 5. Market Complaints and Feedback

• Establish a system for handling complaints

• Maintain complaint logs

• Evaluate whether complaint trends signal safety issues

🔹 6. MDD Inspections or Market Surveillance

The Department of Health may:

• Conduct unannounced audits on the LRP

• Collect samples for testing

• Request internal records or evidence of PMS activities

Prepare:

• Updated QMS documentation

• Copies of certificates and labeling

• Access to technical files (or summary thereof)

🔹 7. Voluntary Withdrawal of Device Listing

If you wish to stop marketing the device in Hong Kong:

• Notify MDD via a formal withdrawal letter

• Include:

  • Device listing number

  • Reason for withdrawal

  • Confirmation of cessation of supply

• Maintain traceability records for 5 years post-withdrawal

📝 Summary: After MDACS Approval for Class C Devices

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