Documenting the Medical Device Technical File Structure (SFDA)

Navigating SFDA medical device regulations is critical to achieving market success in Saudi Arabia. At Bio-Standards, we specialize in preparing medical device technical files and regulatory submission dossiers that make your compliance journey seamless. Our regulatory experts build meticulously tailored technical documentation, delivered as a complete technical file or as section-specific support, to meet the exact Saudi Food & Drug Authority (SFDA) requirements for your device.

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Medical Device Technical File Structure: Your SFDA Compliance  Blueprint

• Medical Device Description and Specifications: A detailed overview of the device, including variants and applications, with a clear focus on intended use and operating principles.
• Manufacturer Information & Labeling: Manufacturer details, instructions for use (IFU), and labeling that ensure the safe and compliant application of your device.
• Design and Manufacturing Information: Documentation of your design and manufacturing processes that demonstrates adherence to Saudi Food & Drug Authority (SFDA) and ISO standards.
• Essential Principles of Safety and Performance (ESP): Conformity with the Essential Principles (ESP) checklist, confirming your device meets the safety and performance requirements defined by the SFDA.
• Benefit-Risk Analysis and Risk Management: Evaluation of clinical benefits against residual risks, supported by a structured risk management plan aligned with ISO 14971.
• Pre-clinical Information: Laboratory testing and pre-clinical evaluations that confirm your device’s safety and performance.
• Clinical Data Evaluation: A robust clinical evaluation that validates the device’s clinical safety and performance for its intended purpose.
• Post-Market Surveillance (PMS) Plan and Report: A continuous post-market surveillance strategy for the ongoing safety monitoring of your device.
• Post-Market Clinical Follow-up (PMCF) Plan: A structured plan to collect post-market clinical data that confirms long-term safety and efficacy.
• Declaration of Conformity: Formal confirmation of your device’s conformity with the Saudi medical device regulations and SFDA requirements.
• High-Risk Device Specifics: The additional documentation required for high-risk medical device classifications, ensuring a rigorous evaluation process.

Our support extends to usability documentation, PMS plans, and process validations, ensuring comprehensive compliance documentation.

Partner with Bio-Standards for expert SFDA medical device regulatory support. Our regulatory team helps you prepare accurate technical files and submission dossiers efficiently, so you can move closer to market approval in Saudi Arabia. Contact us today to get started.