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 can 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