Cracking COFEPRIS: The Critical Stages After Your Mexican Device Submission

Medical Device Global Market Access

This episode demystifies the complex journey a medical device registration takes in Mexico *after* the initial dossier is submitted to COFEPRIS. We explore the critical post-submission phases, from the initial review and the dreaded 'prevención' (request for information) to the final certificate issuance and vital post-market responsibilities. Learn about the different review pathways, including the Standard, Equivalency, and Third-Party Reviewer (TPR) routes, and understand the crucial steps needed to maintain your registration long-term. Key Questions: • What really happens after you click "submit" on your COFEPRIS application? • How can a 'prevención' (request for information) impact your registration timeline? • Is a manufacturing facility inspection always required? • What are the differences between the Standard, Equivalency, and Third-Party Review pathways? • Why is checking your final registration certificate for errors so critical? • How long is a COFEPRIS registration valid and what does the renewal process involve? • What changes to your device or company require a formal modification with COFEPRIS? • Can using a Third-Party Reviewer (TPR) actually speed up your approval? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.