Mexico starts the New Year with new guidelines to apply for drugs and medical devices marketing authorizations.

January 10, 2024

The Federal Commission for Protection against Health Risks (COFEPRIS) announced the elaboration of two guidelines on prior requirements to the submission of marketing authorizations, one guide for medical device applications and the other for drug applications.

These guidelines are expected to facilitate, standardize and keep updated the criteria for the integration of information into the dossier of these health supplies, to make their content much clearer, and to speed up processes and response and approval times for these applications by the regulatory authority. OLIVARES is updated on the regulatory improvements for health products in our country and in compliance with the needs of our customers we follow up on the implementation of these guidelines.