This episode of MENA MedTech Insights tackles one of the most significant hurdles for device manufacturers entering Jordan: the Legalized Free Sale Certificate (FSC). We demystify the stringent requirements set by Jordan's JFDA under Law 21 of 2014, moving beyond the basics to uncover the specific, multi-step legalization process that trips up even experienced companies. We explore why a simple certificate of free sale isn't enough and detail the precise chain of authentication required, from your local health authority to the Ministry of Foreign Affairs, and finally, to the Jordanian Embassy. This is a must-listen for any regulatory affairs professional or business leader looking to expand into the increasingly lucrative Jordanian and wider MENA markets. Consider this real-world scenario: a leading diagnostics firm secured a major distribution deal in Jordan, but their market entry was frozen for three months. The reason? Their Free Sale Certificate was authenticated with a standard international apostille, but it was missing the one specific stamp the JFDA demanded—the legalization seal from the Jordanian Embassy in their home country. This single oversight jeopardized their launch and revenue targets. Key Takeaways From This Episode: - What is the difference between a standard FSC and the "legalized" version the JFDA requires? - What specific two-step authentication process must be completed in your country of origin before submission? - Why does the JFDA reject internationally recognized apostilles for FSCs? - How can a documentation error, like a missing embassy stamp, halt your entire market access strategy in Jordan? - What are the common pitfalls to avoid when preparing your dossier under JFDA Law 21 of 2014? - How does the legalization process serve as proof of authenticity for Jordanian authorities? - Are there ways to expedite the legalization chain for your regulatory documents? Don't let procedural details derail your MENA expansion. At Pure Global, we provide end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise with advanced AI tools to streamline global market access. From initial strategy and dossier submission to acting as your official in-country representative, we manage the complexities so you can focus on growth. Contact us to secure your market access at [email protected] or visit https://pureglobal.com/.