COFEPRIS accepts MDSAP as an alternative to a certificate of good manufacturing practices for medical devices.
IPS, Regulatory Update
Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
IPS, Regulatory Update, Logistics
On August 11, 2025, the Agreement establishing actions for the simplification of procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF).
IPS, Medical Devices, Regulatory Update
On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs.
IPS, Medical Devices, Regulatory Update
On July 11, 2025, COFEPRIS published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures.
