Nov 25, 2020

The Mexican Ministry of Health has set new review timeframes of five business days for medical devices submitted according to equivalency routes established with US, Canadian and Japanese regulators in 2010 and 2012.

A new decree (link in Spanish) from the ministry reduces Mexican medical device market regulator COFEPRIS’s approval times for equivalency route submissions from 15 business days to five for qualifying devices and technologies that have previously obtained market authorizations from the US Food and Drug Administration, Health Canada or Japan’s Ministry of Health, Labour and Welfare (MHLW). Through the expedited review program, COFEPRIS has aimed to provide manufacturers of qualifying devices faster access to the Mexican market with fewer registration requirements. 

Reducing COFEPRIS backlogs—and reliance on third-party reviews

According to Emergo by UL consultants in Mexico City, the new five-day review timeframe for qualifying devices seems very ambitious considering that the equivalency program’s previous 15-day deadlines were often not met. Nonetheless, the new decree reflects efforts by COFEPRIS and the Ministry of Health to reduce overall timeframes as well as documentation requirements for equivalency reviews.

By setting more aggressive review timeframes, Mexican regulators may reduce overall backlogs of device registration applications and expand public access to healthcare products in the country. In addition, Mexican officials have indicated their intentions to increase their oversight and leverage over Third Party Review (TPR) providers, which a more efficient equivalency review program could help support. Although Mexican authorities previously encouraged greater use of TPR providers to help address regulatory logjams, a renewed focus on corruption allegations aimed at some of these entities has prompted greater scrutiny of the TPR system.

Emergo by UL sources expect COFEPRIS to face challenges regarding the five-day approval goal, the new decree may have some real impact in terms of improving expedited review timelines and ultimately increasing Mexican public access to devices previously cleared or approved for sale in the US, Canada or Japan.

Learn more about medical device and IVD registration and approval in Mexico:



  • Stewart Eisenhart