Apr 29, 2020

Mexico’s Federal Commission for Protection from Sanitary Risks (COFEPRIS) has responded to the global COVID-19 emergency by temporarily suspending most administrative activities and by publishing lists of medical devices and IVDs to be given priority in processing.

COFEPRIS suspends activities to prevent unnecessary personal contact

Among regulatory bodies governing medical devices, COFEPRIS is one of the few to still require in-person contact for all registration and post-approval applications, meaning that social distancing protocols have caused a major disruption to its ability to conduct administrative activities. By late March, COFEPRIS was reportedly allowing visits by appointment only.

On March 26, announcements were published in the Diario Oficial de la Federación, stating the following:

  • COFEPRIS had suspended all administrative activities effective immediately and until April 19.
  • Additionally, all deadlines and proceedings on legal terms were likewise to be paused until April 19.

While COFEPRIS remained officially closed, some staff did remain at work to review a limited number of applications, and communications on Twitter stated that matters relating to COVID-19 would be prioritized. At this stage it was not clear which applications would or would not be accepted for review during the period of suspended activity.

COFEPRIS issues emergency plan and extends suspension of normal activities

On April 2 COFEPRIS published a blog entry on its website outlining an emergency plan to be followed during the COVID-19 crisis. A further update was published on April 7. The elements of this plan remain in effect at present:

  • COFEPRIS continues administrative functions and prioritizes COVID-19 related processes. However, in-person services are only open for COVID-19 related​ procedures, limited applications, and renewals.
  • ​Importation permits will be processed immediately (by COFEPRIS and the Secretary of Foreign Relations (SRE) jointly).
  • The National Center of Disease Control and Preventive Programs (CENAPRECE)​ shall issue technical approval letters for the expedited marketing approval of ventilators.
  • The Institute of Epidemiological Diagnosis and Reference (InDRE) shall issue technical approval letters in evaluation of PCR tests for SARS-CoV-2 for their immediate registration and marketing approval. The validity of this approval will be as long as the period of emergency. ​
  • Expedited importation and exportation procedures may also be completed on the Ventanilla Única de Comercio Exterior (VUCEM) portal.​

On April 17, COFEPRIS announced that the temporary hold on administrative activities (other than the priority tasks outlined in the emergency plan) would be extended to April 30. A further extension has not yet been announced at the time of this writing, although a subsequent blog post offered clarification on how to contact COFEPRIS offices in line with social distancing protocols.

Learn how other device markets are responding to COVID-19.

Guidance on ventilators and a list of priority devices and procedures

On April 6 the COFEPRIS website published a guidance dealing with ventilation devices required for mitigating the COVID-19 emergency, in association with the National Center for Health Technology Excellence (CENETEC), the National Center of Disease Control and Preventive Programs (CENAPRECE), and others. This guidance provides the minimal requirements that ventilators must comply with in order to be utilized for COVID-19 treatment.

Finally, COFEPRIS released an official list containing medical equipment and administrative procedures to be prioritized for processing during the COVID-19 emergency.

Learn more about Mexican medical device regulatory requirements at Emergo by UL:

Author

  • Timothy Herr

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