Apr 27, 2022

If you are a medical device manufacturer doing business in Mexico, you will be interested to know some Important news published earlier this year in Mexico’s Official Journal. The announcement contains details affecting most if not all medical device submissions.

The agreement (link in Spanish) modifies former agreements outlining the requirements and procedures to be followed when submitting most types of applications to Mexico’s medical device regulatory agency, COFEPRIS. This new agreement is meant to set the grounds for all digital applications. Even though we have been submitting renewals online for months, this is the first publication officially addressing the specifics of these processes.

Though the agreement covers submissions for all health supplies, the medical device highlights include:

  • Warehouse licenses: Can now only be submitted online.
     
  • Good Manufacturing Process (GMP) Certification: New timelines, requirements and forms for GMP certification and export authorization inspections.
    • Timeline is extended from 15 business days to 90
    • Video remote inspections are considered
    • These can only be submitted online now
       
  • Renewals: Based upon Mexico’s Regalmento de Insumos para la Salud (RIS) June update of the Health Supplies Regulation (link in Spanish), specifically Article 190 bis 3 and bis 4, there are new unique identification numbers (homoclaves) for first and second renewals. (Previous unique homoclaves associated with route or class are now merged into two new ones.)
    • First renewal’s review timeline is 120 calendar days (COFEPRIS 2022-022-002-A)
    • Second and further renewals’ approval is immediate (COFEPRIS 2022-022-006-A)
    • The new homoclaves are implicitly meant for online submissions
       
  • Modifications: New modification homoclaves for digital submissions are now comprised within:
    • Administrative modifications, excluding rights transfers (COFEPRIS-2022-022-003-A) will be reviewed within 22 business days
    • Technical modifications (COFEPRIS-2022-022-004-A) will now be reviewed within 22 business days
    • Rights transfer modifications (COFEPRIS-2022-022-05-A) will now be reviewed within 22 business days
       
  • Registrations: All medical device registrations may now be submitted online, but not until the homoclave is available at the COFEPRIS submission website: https://tramiteselectronicos02.cofepris.gob.mx/Frontendnuevoportal/login.aspx
     
  • Additional considerations:
    • The COFEPRIS form contains additional notes indicating that all the documentation shall be submitted foliated downwards (which will become mandatory in 60 calendar days) and that communications and notifications about follow up or status generated from the documentation review may be sent by email, by the user’s request
    • COFEPRIS will publish the list of accepted equivalent documentation for GMP certification

Emergo by UL will post updates to these regulations as they become available.

Learn more about medical device regulatory advisory services for Mexico from Emergo by UL:

Author

  • Kathryn Burke's picture
    Kathryn Burke

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