Safety Data (Step 5)

Overview

Step 5 collects and organizes post-market safety surveillance data from major global medical device vigilance databases. This data provides the evidence base for subsequent risk assessment and benefit-risk analysis.

Workflow

1. Automated retrieval: AI automatically fetches data from multiple public databases
2. Confirm database status: Confirm search status for each database
3. Supplementary upload: Upload exported results for databases requiring manual search
4. Review and approve: Confirm data completeness

Data Sources

Database	Country/Region	Retrieval Method	Description
FDA MAUDE	USA	Automatic + supplementary upload	Adverse event reports
FDA Recalls	USA	Automatic	Product recall information
Swissmedic FSCA	Switzerland	Automatic	Field safety corrective actions
MHRA Alerts	UK	Automatic	Medical device safety alerts
BfArM FSCA	Germany	Automatic	Field safety corrective actions
TGA DRAC	Australia	Manual upload	Recall/alert/corrective actions

INFO

The system automatically retrieves data from databases marked "Automatic". For TGA DRAC, users must search the official website and upload the exported file (XLSX/CSV format).

Safety Data Checklist

Before executing Step 5, complete the safety data confirmation checklist:

• Confirm status for each database:
  • Auto-fetched -- System retrieved data successfully
  • Searched with results -- Upload exported results file
  • Searched no results -- Confirmed search but no relevant data
  • Not searched -- Only for optional databases

Uploading Supplementary Data

For databases requiring manual supplementation:

1. Visit the relevant official database website
2. Export search results (PDF, XLSX, CSV formats supported)
3. Upload files in the Step 5 panel
4. System automatically parses and extracts key information

Next Step

→ Safety Data Analysis (Step 6)