IPS, Medical Devices, Regulatory Update
IPS
COFEPRIS Enables Regulatory Reliance Through ...

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.

COFEPRIS Enables Regulatory Reliance Through Abbreviated Pathway
IPS, Medical Devices, Regulatory Update
IPS
Unlocking Efficiency: COFEPRIS Modernizes ...

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.

Unlocking Efficiency: COFEPRIS Modernizes Regulatory Framework
IPS, Medical Devices, Regulatory Update
IPS
COFEPRIS Modernizes Medical Device Framework: ...

On July 7, 2025, Mexico’s regulatory authority, COFEPRIS, issued a new decree that substantially revises the classification framework for medical devices, thereby formally repealing the agreements published in 2011 and 2014.

COFEPRIS Modernizes Medical Device Framework: What You Need to Know
Regulatory Update, IPS
IPS
Simplification of Operating License and ...

COFEPRIS has implemented a series of simplification and modernization measures aimed at streamlining procedures and reducing the regulatory burden for establishments. These actions are part of the federal government’s regulatory improvement policies. This update specifically applies to the Operating License.

Simplification of Operating License and Modification Process for Products and Services
Regulatory Update, Medical Devices
IPS
Revolutionizing Health Product Access in ...

COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.

Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance

Reliance

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Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance

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Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance

COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.