Sep 8, 2020

Mexico’s Ministry of Health published a resolution (link in Spanish) on September 1, declaring that all administrative activities and regulatory procedures previously suspended on March 26 due to the COVID-19 emergency will resume, effective immediately.

COFEPRIS will process registrations and extend deadlines

This new resolution features three clauses, declaring that:

  • All processes currently before the Ministry of Health are to resume their regular courses as of September 1.
  • For all product renewals that should have been submitted throughout the suspension period (March 26 to September 1), COFEPRIS will automatically extend their registrations’ validity for another 180 days. Responses to COFEPRIS letters that were due during the suspension period will receive an additional 30 calendar days to be submitted.
  • COFEPRIS will keep the general population apprised of the requirements for setting up appointments and initiating regulatory submissions. This relates to the announcement in late August of a new electronic system that will be used to submit applications and schedule in-person meetings, eliminating unnecessary interactions that could spread COVID-19.

Learn more about Mexican medical device regulatory processes:

Author

  • Timothy Herr

Related