Jun 14, 2018

EMERGO SUMMARY OF KEY POINTS:

  • Mexico’s COFEPRIS has issued simplified guidelines for medical device digital advertising campaign processes.
  • The guidelines cover proprietary content developed by manufacturers as well as third-party content disseminated via social media channels.

Mexico COFEPRIS simplified guidelines for medical device digital advertising 2018Medical device market regulators in Mexico have published new simplified guidelines for digital advertising campaigns related to medical devices and other healthcare products.

The new guidelines (link in Spanish) from COFEPRIS, the Mexican healthcare regulatory agency, include social medial recommendations as well as content recommendations for manufacturers, users and third parties.

Advertising content guidelines

COFEPRIS guidelines cover both proprietary digital content developed by manufacturers as well as “variable” content about a device or product published by third parties or consumers through social media and other venues.

Among recommendations and requirements are:

  • Companies must submit digital advertising authorized request forms and submit all campaign materials to COFEPRIS before launching digital advertising campaigns.
  • Online materials including social media content and brand web pages must also obtain COFEPRIS authorization before publication.
  • Companies should designate staff (“community managers”) to manage digital advertising permit requests and monitor both in-house and third-party advertising content regarding their devices to ensure that any content does not go beyond its COFEPRIS-authorized context.
  • Community managers should oversee any corrective actions and take down any advertising content that is found to be noncompliant with COFEPRIS advertising guidelines and requirements.
  • A company’s digital advertising and social media campaigns must feature COFEPRIS digital advertising permit numbers.
  • Companies whose campaigns violate their COFEPRIS-authorized context must correct their materials within 24 hours of receiving electronic notice of such violations from the regulator.

Related Mexican medical device regulatory market resources: