Post-Market Surveillance Plan

MDD Hong Kong · MDACS · LRP obligations · TR-008

Overview

MDACS-listed devices must be supported by an ongoing post-market surveillance (PMS) system. For higher-risk devices (Class III, IV, and equivalent IVDs), a formal PMS plan is expected as part of the listing documentation, with post-market clinical follow-up (PMCF) for devices where pre-market clinical evidence was limited.

PMS Plan Elements

A compliant PMS plan must address:

Element	Description
Complaint collection	System for receiving product complaints from Hong Kong users, healthcare facilities, and distributors
Complaint evaluation	Decision framework — does the complaint constitute a reportable adverse event?
Adverse event monitoring	Review of data from Hong Kong users, MDD notifications, international vigilance databases
Literature surveillance	Periodic review of published literature for safety signals
FSCA monitoring	Tracking FSCAs initiated in other markets for the same device
CAPA system	Process for implementing and verifying corrective and preventive actions
Periodic PMS review	Regular internal review (at least annually) of accumulated PMS data
Risk management feedback	Mechanism to update the ISO 14971 risk management file based on PMS findings

Post-Market Clinical Follow-Up (PMCF)

For Class III and IV devices — and for lower-class devices where pre-market clinical evidence was limited — PMCF is expected. PMCF activities include:

• Systematic analysis of Hong Kong post-market experience
• Participation in device registries (where available)
• Post-market clinical studies (where pre-market data is insufficient)
• Structured collection of real-world clinical outcome data from Hong Kong users

PMCF findings must be incorporated into the periodic PMS review and used to update the clinical evidence base.

Complaint Handling

All product complaints from Hong Kong users must be:

1. Received and logged in a complaint register
2. Evaluated — does the complaint meet the adverse event reporting threshold?
3. Investigated — root cause analysis for events meeting the threshold
4. Responded to with CAPA where a systemic issue is identified
5. Reported to MDD via the adverse event reporting system if reportable

See Adverse Event Reporting for reporting obligations and timeframes.

CAPA Process

Step	Action
1. Problem identification	Document the complaint, adverse event, audit finding, or PMS signal
2. Root cause analysis	Investigate the underlying cause
3. Corrective action	Implement the fix
4. Preventive action	Address the systemic cause to prevent recurrence
5. Effectiveness check	Confirm the CAPA worked
6. Closure	Document with evidence

Distribution Records

The LRP must maintain distribution records to enable traceability of any device or lot from receipt to end customer:

• Customer name and contact
• Device model and lot/batch number
• Date and quantity supplied

Essential for effective recall execution. See FSCA & Recalls.

Periodic PMS Review

Conduct a periodic review of all PMS data — at minimum annually. Review should assess:

• Complaint frequency and trends
• All adverse events reported during the period
• Status of open CAPAs
• International FSCAs involving the same device
• Literature updates on device safety and performance

Document the review and retain records for MDD inspection.

PMS and Risk Management Integration

PMS findings must feed into the device's ISO 14971 risk management file. If PMS reveals a new hazard, higher-than-expected adverse event rate, or an ineffective risk control, update the risk management file. Significant changes affecting the benefit-risk profile or labelling may require a listing variation before implementation — notify MDD.