After successfully obtaining Class D medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, there are several post-listing obligations and key compliance responsibilities that the Local Responsible Person (LRP) and manufacturer must continuously fulfill. These obligations ensure that the device remains safe, effective, and in compliance throughout its lifecycle on the Hong Kong market.

Below is a detailed breakdown of what you must note and comply with after obtaining Class D MDACS registration:

✅ 1. Maintain Validity of the Registration

• MDACS listing is valid for 5 years.

• You must apply for renewal before expiration by submitting:

  • Updated technical documentation (if applicable)

  • Declaration of continued compliance

  • Summary of post-market experience (if available)

🕒 It is recommended to begin the renewal process at least 6 months before expiry.

✅ 2. Monitor and Report Adverse Events (Vigilance Reporting)

• Class D devices require prompt reporting of adverse incidents that:

  • Led or may lead to death or serious injury

  • Are due to device malfunction, deterioration, or incorrect use

• Submit reports through the MDIS (Medical Device Information System) portal.

• You must follow the timeline outlined in GN-10 (Guidance Notes for Adverse Event Reporting):

  • Serious threat to public health: report within 2 calendar days

  • Death or serious deterioration: within 10 calendar days

  • Other reportable events: within 30 calendar days

✅ 3. Conduct and Maintain Post-Market Surveillance (PMS)

You are responsible for a proactive post-market surveillance system:

• Collect and evaluate real-world data from users, complaints, distributors

• Analyze trends in adverse events or malfunctions

• Maintain a documented PMS plan (required in initial registration)

• Submit summary reports upon MDD request

✅ 4. Handle Field Safety Corrective Actions (FSCA) and Recalls

If your product presents a safety risk post-marketing, you must:

• Immediately implement a Field Safety Corrective Action (FSCA), such as:

  • Device modification

  • Software update

  • Use restriction

  • Product recall

• Notify MDD and affected users without delay

• Submit a Field Safety Notice (FSN) using MDIS

• File a final report on the outcome of the corrective action

Refer to GN-11 (Field Safety Corrective Actions Guidance) for details.

✅ 5. Maintain Technical Documentation and Traceability

• Keep all technical documentation and QMS records current and accessible for audit

• Retain all documents for at least 5 years beyond the product’s last date of supply

• Ensure full traceability of distributed devices in Hong Kong:

  • Serial numbers

  • Batches

  • Distribution records

  • End users (if required)

✅ 6. Communicate Product Changes to MDD

You must notify the MDD of any significant post-approval changes, such as:

Failure to notify may result in de-listing of the device.

✅ 7. Retain Valid Quality Certifications

• The manufacturer must maintain valid ISO 13485 QMS certification

• If QMS certification lapses or is suspended:

  • You must inform the MDD immediately

  • MDD may suspend or revoke device listing

✅ 8. Display and Use MDACS Listing Number Properly

• The MDACS listing number should be used in:

  • Distributor catalogs

  • Internal quality records

  • Regulatory correspondence

• Do not misrepresent it as “official government approval” since MDACS is a voluntary system

• You may indicate: “This product is listed under the Medical Device Administrative Control System (MDACS) in Hong Kong.”

✅ 9. Be Prepared for Audits or Requests for Information

• MDD may request:

  • Technical file review

  • Market performance data

  • Adverse event analysis

• Be ready to provide full documentation within a short notice period

✅ 10. Coordinate with Importers and Distributors

• Ensure all distribution partners:

  • Understand their obligations for traceability and AE reporting

  • Are trained on the product’s use, labeling, and risk profile

• Establish clear Standard Operating Procedures (SOPs) for complaint handling and escalation

📌 Summary Table: Post-MDACS Registration Obligations for Class D Devices

Would you like a post-registration compliance checklist or an editable FSCA/AE reporting SOP template for your Class D device? I can prepare one for your RA team.

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