Pure Global: Mexico's DigiReg Shift - Navigating COFEPRIS's Simplification Paradox

In this episode of LATAM MedTech Insights, we dissect the chaotic rollout of COFEPRIS's new mandatory digital platform, 'DigiReg'. Launched in the last week of December 2025, this platform was meant to be the final step in simplifying medical device registration in Mexico. Instead, it has created a maze of technical glitches and undocumented requirements. We explore how this "simplification paradox" is catching foreign manufacturers off guard. For instance, a leading European diagnostics firm found their application for a new IVD product stalled. They were perfectly compliant with the rules published just months ago, but the DigiReg platform is now rejecting their submission due to cryptic data validation errors, with no clear guidance from COFEPRIS on how to resolve them, putting their entire market entry strategy at risk. Key Takeaways for this episode: - What are the top three undocumented requirements in the new DigiReg platform causing immediate rejections? - How has the supposedly 'simplified' registration pathway become more complex for foreign manufacturers? - Why is your existing technical dossier suddenly non-compliant with the new digital standards? - What are the critical advantages of having a local representative to navigate DigiReg's interface and communication hurdles? - How can you adapt your submission strategy to avoid the common pitfalls of this new system? - Are there any workarounds for the platform’s current technical glitches to keep your registration on track? Navigating sudden regulatory shifts in fast-moving markets like Mexico is our expertise. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. With our local experts in Mexico and advanced AI tools, we streamline the entire submission process, ensuring your technical dossier meets the latest digital requirements of platforms like DigiReg. Don't let regulatory surprises delay your market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.