Post-Market Overview
CDRRHR · DOH AO 2015-0001 · PH-Unique features
Summary of Post-Market Obligations
| Obligation | Responsible Party |
|---|---|
| Adverse event reporting (eReport) | License holder / local rep |
| FSCA / recall coordination | License holder + manufacturer |
| Post-market surveillance | License holder + manufacturer |
| Distribution record-keeping | License holder / importer |
| CMDN/CMDR maintenance | License holder |
| LTO maintenance | License holder / importer |
| Labelling compliance | License holder / importer |
| CDRRHR cooperation | License holder |
Adverse Event Reporting
Report to CDRRHR any adverse event where a registered device:
- Caused or contributed to death or serious injury
- Malfunctioned in a way that could cause death or serious injury if recurrence occurred
- Presents a serious public health concern
eReport System — PH-Unique
Adverse event reports are submitted through the FDA Philippines eReport system — an online platform for electronic submission of adverse event and post-market reports.
Key features of eReport:
- Online submission (no physical paper filing required)
- Case tracking and follow-up through the system
- System available from the FDA Philippines website
Timeframes:
- Events involving death or serious injury: as soon as possible (within 10 days)
- Other reportable events: within 30 days
Field Safety Corrective Actions (FSCAs)
- License holder notifies CDRRHR before or simultaneously with user notification
- Prepare and distribute Field Safety Notice (FSN) to all known users/distributors
- Implement corrective action (recall, modification, relabelling)
- Maintain complete FSCA records
- Report completion to CDRRHR
Bureau of Customs & Unnotified Device Interception — PH-Unique
CDRRHR coordinates with the Bureau of Customs to intercept shipments of recalled or unregistered devices at ports of entry. Where an FSCA requires stopping importation of affected devices, notify CDRRHR promptly so they can coordinate with BoC.
Post-Market Surveillance
The license holder maintains a PMS system under DOH AO 2015-0001:
- Collecting user feedback and complaints
- Monitoring literature and international adverse event databases
- Tracking FSCAs in other markets
- Feeding findings into the device's risk management process
Regional Field Office Monitoring — PH-Unique: CDRRHR's Regional Field Offices conduct ongoing market surveillance throughout the Philippines. Compliance monitoring is decentralised — local distribution networks are subject to regional FDA inspection.