This episode of MENA MedTech Insights offers a deep dive into the technical documentation required by the Saudi Food and Drug Authority's (SFDA) MDS-G5 guidance. We break down the critical components of a successful technical file submission, from device descriptions and risk management to clinical evaluation reports, for MedTech and IVD companies targeting the Saudi Arabian market.

We explore the common pitfalls that can lead to significant delays and rejections. For instance, a promising MedTech startup with an innovative diagnostic tool faced a six-month setback and costly revisions. Their mistake? They submitted a generic technical file that passed in Europe but failed to address SFDA's specific requirements for local labeling in Arabic and lacked a comprehensive risk analysis for the local patient population, halting their market entry and straining investor relations.

Key Takeaways:

- What are the five essential pillars of the SFDA MDS-G5 technical file?

- Why is the ISO 14971 risk management file a common point of failure for SFDA submissions?

- Does your Clinical Evaluation Report (CER) meet Saudi-specific requirements?

- How can improper labeling and Instructions For Use (IFU) derail your entire application?

- What role does existing approval from GHTF-founding members play in the SFDA review process?

- Are you prepared for the Arabic language requirements for your submission?

- How do you demonstrate conformity to the Essential Principles of Safety and Performance effectively?

At Pure Global, we specialize in transforming these complex regulatory challenges into clear market access strategies. Our team combines local Saudi expertise with advanced AI tools to ensure your technical documentation is flawless and fully compliant with SFDA standards, accelerating your time-to-market. Contact us for end-to-end regulatory consulting at [email protected] or visit https://pureglobal.com/.