Post-Market Overview
Ongoing obligations after MDMA
Obtaining MDMA is not the end of regulatory compliance — it is the beginning of an ongoing lifecycle of obligations. The SFDA requires manufacturers and their ARs to actively monitor device performance, report safety issues, and maintain their registration throughout the device's commercial life in Saudi Arabia.
Key post-market obligations
| Obligation | Who | Frequency / trigger |
|---|---|---|
| PMS Report (Class A) | Manufacturer / AR | As needed; available on SFDA request |
| PSUR (Class B) | Manufacturer / AR | At least every 2 years |
| PSUR (Class C and D) | Manufacturer / AR | Annually |
| Adverse event reporting | Manufacturer, AR, healthcare providers | Per NCMDR timeframes |
| FSCA coordination | Manufacturer / AR | When a safety issue is identified |
| MDMA renewal | AR | Before certificate expiry |
| Change notification | AR | On significant device change |
| UDI maintenance | Manufacturer / AR | On any UDI-relevant change |
| Labelling update | Manufacturer / AR | On AR change or significant label change |
The role of the AR in post-market compliance
The AR is the primary point of contact for all SFDA post-market interactions in Saudi Arabia. The manufacturer must ensure their AR is:
- Receiving all PMS/PSUR data from the manufacturer's global PMS system
- Equipped to report adverse events to the NCMDR
- Prepared to coordinate FSCAs with Saudi healthcare facilities and distributors
- Monitoring for regulatory updates and new SFDA requirements