ORBIS Compliance

New Digital Process for Sanitary Supplies and Medical Equipment Extensions

Published /Mexico

Changes in Extension Processes

On January 24th, 2022, significant changes pertaining to the extension processes of sanitary supplies and medical equipment came into effect. These changes were published in the DOF (Diario Oficial de la Federación).

Digital Transformation

Applications and the entire extension process have transitioned to a digital format, thereby shortening process times and optimizing deadlines.

COFEPRIS Management

The processes will be managed directly by COFEPRIS (the Medical Regulator in Mexico). Applications can now be submitted at any time to prevent shortages, and the notifications of application acceptance have been removed. All requests will be permitted, and internal processes have been streamlined to allow for digital follow-up through the COFEPRIS portal.

New Lead-Times

The significant changes in lead-times for extensions are as follows:

  • Supplies: 15 working days.
  • Medical devices or equipment: Immediate.

This modification applies exclusively to the extension processes.

Mexico Quick Facts

Regulatory AgencyIFT (Instituto Federal de Telecomunicaciones)
Certification TypeMandatory
License ValidityFinal Homologation Certificate: permanent
Application LanguageSpanish
Legal License HolderRequired
In-country Testing RequirementDepending on the product

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