Mexico's regulatory authority, COFEPRIS, has just launched its mandatory all-digital submission platform, DigiPRIS. While this move promises to streamline market access, the initial rollout has created significant and unexpected challenges for medical device manufacturers, leading to submission errors, delays, and uncertainty.

This episode of LATAM MedTech Insights unpacks the chaotic first week of the new system. We share a real-world case study of a cardiovascular device company whose complete digital submission vanished from the COFEPRIS portal without a trace after being successfully uploaded. This costly setback highlights the critical need for navigating the platform's undocumented requirements and technical instability.

Key Takeaways in this episode:

- What are the unwritten rules and hidden formatting requirements of the new DigiPRIS platform?

- How can you verify your digital submission is secure and correctly processed by COFEPRIS?

- What is the new timeline for approvals, and how does the digital system impact it?

- Which device classes are most affected by the platform's initial instability?

- What is the most effective way to communicate with COFEPRIS about a digital submission error?

- How should you adapt your regulatory strategy to mitigate the risks of this digital transition?

- Are there new cybersecurity concerns for your technical dossier on the DigiPRIS platform?

At Pure Global, we specialize in navigating these complex regulatory shifts. Our local experts in Mexico combined with our advanced AI tools provide the real-time support needed to overcome digital barriers and ensure your product gets to market efficiently. Don't let digital chaos derail your launch. Contact Pure Global at [email protected] or visit https://pureglobal.com/.