How to Prepare ISO 14971 Risk Files for SFDA Registration

Why SFDA Specifically Scrutinizes Risk Management Files

The Saudi Food and Drug Authority (SFDA) has increasingly aligned its Technical File Assessment (TFA) process with international standards — most notably ISO 14971:2019 for risk management and ISO 13485:2016 for quality management systems. However, SFDA reviewers apply their own interpretive lens, particularly around benefit-risk justification and post-market surveillance integration.

A compliant Risk Management File (RMF) is no longer optional. Even Class A (Class I equivalent) devices submitted through the SFDA's GHAD system must include a documented risk management process. Deficient risk files are among the top three reasons for SFDA Technical File rejection — making this document critical for successful market access.

Step 1: Start with the Risk Management Plan

Every ISO 14971-compliant RMF begins with a Risk Management Plan (RMP). This document defines the scope, responsibilities, and criteria that will govern your entire risk process. For SFDA submissions specifically, your RMP should address:

• Scope and intended use: Define the device, its intended markets (including KSA), and all reasonably foreseeable uses and misuses
• Risk acceptability criteria: Define your severity and probability scales, and the risk matrix that determines what constitutes acceptable, ALARP, and unacceptable risk
• Applicable standards: Reference ISO 14971:2019, ISO/TR 24971, and any SFDA-specific guidance documents
• Post-market feedback loop: Describe how post-market data (complaints, vigilance reports) feeds back into the risk analysis

Pro tip: SFDA reviewers expect to see your risk acceptability criteria clearly defined before any hazard analysis begins. Don't bury this in an appendix — make it prominent in Section 2 or 3 of your RMP.

Step 2: Conduct a Systematic Hazard Analysis

Using your RMP criteria, systematically identify all hazards associated with your device. ISO 14971 doesn't prescribe a single method, but SFDA reviewers are most familiar with:

• FMEA (Failure Mode and Effects Analysis): Bottom-up analysis of component/process failures — ideal for electromechanical devices
• FTA (Fault Tree Analysis): Top-down analysis starting from undesirable events — useful for software-intensive or complex systems
• HACCP/HAZOP: Systematic deviation analysis — commonly used for in-vitro diagnostic devices and process-oriented assessments

For each identified hazard, document the hazardous situation, the harm that could result, and estimate the probability of occurrence and severity of harm. This triad — hazard → hazardous situation → harm — is the backbone of your risk analysis and is explicitly what SFDA reviewers look for.

Step 3: Implement Risk Controls and Verify Effectiveness

For each risk that exceeds your acceptability threshold, implement risk control measures following the ISO 14971 priority:

1. Inherent safety by design — eliminate the hazard entirely through design changes
2. Protective measures — add guards, alarms, interlocks, or engineering controls
3. Information for safety — warnings, labels, and training (least preferred as a sole control)

Critically, each risk control must be verified for effectiveness. SFDA expects evidence — testing reports, design verification results, or clinical data — proving that each control actually reduces risk to acceptable levels. A control measure without verification evidence is a common deficiency.

Step 4: Perform Benefit-Risk Analysis

This is where many SFDA submissions stumble. ISO 14971 requires that any residual risk that exceeds your acceptability criteria be weighed against the clinical benefits of the device. SFDA has adopted this requirement fully and expects a formal, documented benefit-risk analysis.

Your benefit-risk analysis should clearly:

• Identify the clinical benefits (with references to clinical data where available)
• List all residual risks that remain after control implementation
• Provide a justified conclusion on whether residual risks are outweighed by benefits
• Be reviewed and approved by qualified personnel (not just the author)

Step 5: Compile the Risk Management Report

The Risk Management Report is the capstone document that summarizes your entire risk process. It should confirm that:

• The risk management plan was implemented as specified
• The overall residual risk is acceptable
• Methods are in place to collect post-production information
• All relevant hazards were considered (cross-reference your hazard analysis)

Step 6: Integrate Post-Market Surveillance

SFDA — like FDA and EU MDR — expects risk management to be a living process, not a one-time documentation exercise. Your RMF must include mechanisms for:

• Monitoring complaints and field performance data
• Updating hazard analyses when new information becomes available
• Triggering new risk evaluations when design changes occur
• Periodic review of the overall residual risk profile

Common Mistakes We See in SFDA Risk File Submissions

Based on our experience supporting manufacturers through the SFDA TFA process, here are the most frequent issues:

1. No clear risk acceptability matrix — reviewers can't evaluate your risk decisions without defined criteria
2. Missing verification evidence for risk controls — stating "alarm added" without test results is insufficient
3. Incomplete hazard identification — focusing only on normal use while ignoring foreseeable misuse scenarios
4. No benefit-risk analysis — especially common with Class A/B devices where manufacturers assume it's not required
5. Static risk files — no connection to post-market surveillance data

How Regulatory Assist Can Help

Our US-based team of senior medical device engineers has helped dozens of manufacturers build and remediate ISO 14971 risk management files for successful SFDA registration. We provide:

• Complete RMF development from scratch, or remediation of existing files
• DFMEA/PFMEA engineering with structured hazard analysis
• Benefit-risk analysis documentation aligned with SFDA expectations
• Post-market surveillance integration into your living RMF
• Pre-submission review to catch deficiencies before SFDA does

Most projects begin within 24–48 hours. Schedule a free consultation to discuss your device and timelines.