Vigilance & Adverse Event Reporting
CDRRHR · DOH AO 2015-0001 · eReport system · PH-Unique
What Must Be Reported
Report to CDRRHR any event where a Philippines-registered device:
- Caused or contributed to death of a patient, user, or other person
- Caused or contributed to serious deterioration in patient/user health
- Malfunctioned in a way that, if recurrence occurred, could cause death or serious injury
- Creates a serious public health concern
Borderline cases (events that may or may not meet the threshold) should be reported — CDRRHR clearly reportability to CDRRHR the license holder should not make a unilateral determination of whether to report. will investigation advise whether a full report is required.
Reporting via eReport System — PH-Unique
All adverse event reports must be submitted through the FDA Philippines eReport system:
- Access from FDA Philippines website
- Complete the electronic adverse event form
- Attach supporting documentation
- Receive a case reference number
- Track case progress online
Preliminary reports (within the timeframe, even if investigation is incomplete) must be followed by final reports once the investigation is concluded.
Reporting Timeframes
| Event Type | Timeframe |
|---|---|
| Death or serious injury | As soon as possible — within 10 calendar days |
| Public health emergency | Immediately |
| Other reportable malfunction | Within 30 calendar days |
Local Representative Reporting Duties
The Philippines license holder must:
- Establish a complaint handling system
- Receive and evaluate all adverse event reports from users/distributors
- Investigate in coordination with the foreign manufacturer
- File preliminary and final reports via eReport
- Maintain complete investigation records
Field Safety Corrective Actions (FSCAs)
FSCA Trigger
An FSCA is required when a marketed device presents an unacceptable risk not previously identified or newly significant.
FSCA Types
| Type | Description |
|---|---|
| Recall | Return of affected devices |
| Modification | On-site upgrade or repair |
| Labelling correction | Address safety-critical label errors |
| User notification | Alert without physical device action |
FSCA Obligations
- License holder notifies CDRRHR before or simultaneously with user notification
- Prepare and distribute Field Safety Notice (FSN) to all known users
- Track all affected devices using distribution records
- Coordinate with BoC for interception of undelivered imported shipments
- Report FSCA completion to CDRRHR with reconciliation records
Preliminary reports should include initial findings and available case details even if investigation is ongoing. Final reports must include complete investigation findings, causality assessment, and corrective actions taken or planned.