Post-Market Surveillance Plan
DOH AO 2015-0001 · CDRRHR · CAPA · PH-Unique
Overview
License holders for CMDN and CMDR-registered devices must maintain an active post-market surveillance (PMS) system throughout the registration period. PMS is not a one-time submission — it is an ongoing program that feeds information back into the device's risk management process.
PMS Plan Requirements
A PMS plan must be included in the CMDR application (Section 11 of the CSDT) and must address:
| PMS Element | Description |
|---|---|
| Complaint collection | System for receiving and logging user complaints about device performance or safety |
| Complaint investigation | Procedures for evaluating whether a complaint is an adverse event or FSCA trigger |
| Adverse event monitoring | Systematic review of data from users, international vigilance databases, and literature |
| Literature surveillance | Regular review of peer-reviewed literature for safety signals |
| FSCA monitoring | Tracking FSCAs issued in other markets for the same device or equivalent devices |
| CAPA system | Process for implementing and verifying corrective and preventive actions |
| PMS report / periodic review | Regular internal review of PMS data |
| Feedback to risk management | Mechanism to update the risk management file based on PMS findings |
Complaint Handling — Key Requirements
All product complaints must be:
- Received and logged in a complaint register
- Evaluated to determine if the complaint constitutes a reportable adverse event
- Investigated — root cause analysis for complaints that meet adverse event threshold
- Resolved with a documented CAPA where systemic issues are identified
- Reported to CDRRHR via the eReport system if the complaint is a reportable adverse event
Borderline complaints — complaints that may or may not meet the adverse event threshold — should be documented and escalated to CDRRHR for guidance rather than unilaterally dismissed.
CAPA — Corrective and Preventive Action
The CAPA system is the engine of PMS. When a complaint, adverse event, or internal audit identifies a non-conformance or safety signal:
| Step | Action |
|---|---|
| 1. Problem identification | Document the issue — complaint, AE report, internal audit finding |
| 2. Root cause analysis | Investigate the underlying cause — device design, manufacturing, user error, labelling |
| 3. Corrective action | Implement fix — design change, manufacturing correction, labelling update, user training |
| 4. Preventive action | Address systemic cause to prevent recurrence |
| 5. Verification | Confirm the CAPA is effective — follow-up monitoring |
| 6. Closure | Document closure with evidence of effectiveness |
CDRRHR uses CDRRHR-PRSDD-Form 021 to issue formal CAPA requests to license holders following adverse event investigations. Respond within the timeframe specified on the form.
Distribution Records
Maintain records sufficient to trace each device or device lot from receipt to point of sale/delivery:
- Supplier / manufacturer details
- Date of receipt
- Lot/batch numbers received
- Quantity
- Customer / healthcare facility name and contact
- Date of delivery
- Quantity delivered
These records are essential for recall execution and CDRRHR audit. Retain records for the expected device lifetime or as directed by CDRRHR.
PMS Data and Risk Management Integration
PMS findings must feed back into the device's risk management file. If PMS reveals:
- A new hazard not previously identified
- A risk estimate that has changed (e.g. higher frequency of a known event than expected)
- A risk control that is ineffective
...then the risk management file must be updated and, if the change affects the benefit-risk profile, a variation application to CDRRHR may be required.
Periodic PMS Review
Conduct a periodic review of accumulated PMS data — at minimum annually. The review should assess:
- Complaint frequency and trends
- Adverse event rates vs. expected rates
- Outcomes of all open CAPAs
- Updates from international FSCAs or regulatory actions
- Any changes to the regulatory environment affecting the device
Document the review findings and retain records for CDRRHR inspection.