Feb 5, 2016

Mexico’s medical device market regulator COFEPRIS has slated efforts to improve its third-party review (TPR) process and reduce registration timeframes for 2016.

According COFEPRIS as well as Emergo consultants in Mexico City, Mexican regulators intend to implement a more consistent and uniform auditing process for TPRs, which would have the effects of treating all TPRs equally in terms of vetting dossiers as well as improving the quality of all TPRs’ work on behalf of medical device registrants.

COFEPRIS also plans to publish a list of all dossiers submitted by TPRs on its website; TPRs will be required to provide COFEPRIS with lists of all their registration clients so that the regulator can track applications in progress and monitor how long TPR applications are taking.

Also, COFEPRIS plans to schedule meetings on a weekly basis with TPRs wanting to discuss issues such as dossier reviews or any outstanding requests. TPRs will be able to request these meetings via email, and those firms that have filed dossiers for review within the past 20 days of meeting requests will likely be given priority in terms of scheduling with the regulator. COFEPRIS will record unofficial minutes of these meetings that TPRs may use to justify decisions regarding dossier reviews and approvals.

Emergo’s Mexico office will continue monitoring COFEPRIS’s new TPR initiatives and provide any updates as we learn them.

Additional information on Mexico’s medical device registration process is available via our whitepaper, video overview and regulatory process chart.


  • Stewart Eisenhart