Sep 1, 2020

COFEPRIS, Mexico’s medical device and IVD market regulator, has launched an all-electronic appointment system for registrants submitting applications or seeking in-person meetings with the agency. The new system was implemented in order to limit the number of visitors to COFEPRIS facilities and reduce the risk of coronavirus exposure and infection.

Launch of the new system (link in Spanish) coincides with the reopening of the COFEPRIS submission desk that receives registration and related regulatory submissions on September 1, 2020.

COFEPRIS now requires all users to utilize the electronic appointment system in order to request in-person meeting with regulatory officials. Additional key criteria for the new system include:

  • Users may request only one appointment per day;
  • Users must list all  procedures and services to be discussed in their appointment request submissions;
  • COFEPRIS must receive appointment cancellation notifications at least 24 hours prior to scheduled meetings;
  • Any fees associated with appointments must be paid at least 48 hours ahead of scheduled meetings

Emergo by UL consultants in Mexico City will provide updates as they become available regarding how the new COFEPRIS electronic appointment system impacts medical device manufacturers, their Mexico Registration Holders (MRH), as well as registration review and approval timeframes in Latin America’s second-largest medical device market going forward.

Learn more about Mexico’s medical device and IVD regulatory requirements:

 

 

Author

  • Stewart Eisenhart

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