Post-Market Overview
NMRA · MAH post-market obligations · Market Control Division
The MAH's Post-Market Obligations
The MAH bears all post-market obligations for NMRA-registered devices. The NMRA's Market Control Division oversees post-market compliance.
Summary of Post-Market Obligations
| Obligation | Responsible Party | Key Detail |
|---|---|---|
| Adverse event reporting | MAH | Report to NMRA within specified timeframes |
| FSCA / recalls | MAH (with manufacturer) | Notify NMRA before user notification |
| Post-market surveillance | MAH + Manufacturer | Systematic data collection and analysis |
| PSURs | MAH | Periodic Safety Update Reports — higher risk devices |
| PMCF | MAH + Manufacturer | Post-market clinical follow-up where required |
| Advertising pre-approval | MAH | Obtain prior written NMRA approval for all ads |
| Labelling compliance | MAH | Maintain compliance with NMRA Act §77 at all times |
| Annual fees | MAH | Pay NMRA USD-denominated annual fees |
| Change management | MAH | Notify NMRA of post-approval changes |
| Renewal | MAH | Submit renewal before Registration Certificate expiry |
| NMRA cooperation | MAH | Assist market surveillance inspections |
Post-Market Surveillance System
The MAH must maintain a structured PMS system that:
- Collects feedback from users, healthcare facilities, and distributors
- Analyses adverse event trends and performance data
- Monitors published literature for emerging safety signals
- Tracks FSCA actions in other markets (which may indicate risks in Sri Lanka)
- Feeds findings into the device's risk management process
The PMS system must be documented and accessible for NMRA inspection.
Market Control Division
The NMRA's Market Control Division conducts post-market compliance activities:
- Market surveillance sampling and testing
- Compliance monitoring of distribution and labelling
- Post-market inspections of MAH operations
- Coordination of recall actions
MAHs must cooperate fully with Market Control Division activities.