Post-Market Overview
Thai FDA · MDCD · License holder post-market obligations
Summary of Obligations
| Obligation | Responsible Party |
|---|---|
| Adverse event reporting | License holder (AR/importer) |
| FSCAs and recall coordination | License holder + manufacturer |
| Post-market surveillance | License holder + manufacturer |
| Labelling compliance (ongoing) | License holder / importer |
| Thai language compliance | Importer (affixing label) |
| 5-year renewal | License holder |
| Product variation notification | License holder |
| Establishment License renewal | License holder |
| Distribution record-keeping | Importer / license holder |
| MDCD cooperation | License holder |
Adverse Event Reporting
Report to Thai FDA/MDCD 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 it recurred
- Presents a serious public health concern
Reporting timeframes (ASEAN AMDD-aligned):
- Death or serious injury: as soon as possible (within 10 days)
- Other reportable events: within 30 days
Reports are submitted to the Thai FDA/MDCD through the designated reporting channel. Confirm current reporting form and process with MDCD.
Field Safety Corrective Actions (FSCAs)
When a marketed device presents an unacceptable risk:
- License holder notifies MDCD before or simultaneously with user notification
- Prepare and distribute Field Safety Notice (FSN) to all known users
- Implement corrective action (recall, modification, relabelling, user notification)
- Maintain complete FSCA records: affected devices, FSN distribution, confirmation of receipt
- Report FSCA completion to MDCD
Post-Market Surveillance
The license holder must maintain a structured PMS system:
- Collecting user feedback and complaints
- Monitoring literature and adverse event databases
- Tracking FSCAs initiated in other markets
- Feeding PMS findings into the device's risk management process
For Class 3–4 devices, a PMS plan is expected as part of the registration dossier, and MDCD may require PSURs (Periodic Safety Update Reports) at defined intervals.
Distribution Records
Maintain records enabling traceability of devices through the supply chain:
- Customer details (hospital/clinic/distributor)
- Lot/batch numbers supplied
- Delivery dates and quantities
These records are essential for effective recall management.