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
Regulatory Update, IPS
IPS
Health Transformation: Key Incentives for ...

This Decree, published in the Official Gazette of the Federation on June 2, 2025, establishes a regulatory framework aimed at promoting investment within Mexico to strengthen the pharmaceutical industry, the production of medicines, health inputs, and medical devices, as well as fostering scientific research. Its main objective is to reduce import dependency and ensure the availability of these essential products, using consolidated public procurement as a lever for economic development.

Health Transformation: Key Incentives for Investment and Scientific Development in Mexico

Regulatory Update COFEPRIS Simplifies Sanitary Procedures

Regulatory Update COFEPRIS Simplifies Sanitary Procedures

The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through an Agreement published in the Official Gazette of the Federation (DOF) on March 27, 2025, will simplify health supplies procedures. Starting 15 working days after publication, procedures for establishment operation notices (COFEPRIS-05-006) and modifications/cancellations (COFEPRIS-05-007) will be merged, and the requirement to submit the "Operation Notice, Sanitary Responsible, and Modification or Cancellation Notice" form and the "Original Responsible Notice, for the case of sanitary responsible cancellation" will be eliminated.

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Essential Tests for Cosmetics in Mexico: Ensuring Safety and Quality

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Essential Tests for Cosmetics in Mexico: Ensuring Safety and Quality

In Mexico, the safety and quality of cosmetic products are regulated by strict standards. Laboratory tests are essential to ensure that cosmetics meet established standards and protect consumer health. This article details the essential tests required, based on Mexican regulations.

Regulatory Update Self-Verification Guide for cosmetics establishments

Regulatory Update Self-Verification Guide for cosmetics establishments

On December 23, 2024, COFEPRIS published on its website a guide for self-verification of establishments in the cosmetic industry.

The purpose of this guide is to outline the key points to consider for regulatory compliance applicable to all stages of a cosmetic product, from manufacturing and storage to marketing and distribution. It also includes points to consider when receiving a sanitary verification visit from the competent authority.

Regulatory Update New Agreement on Health Supply Import Permits Ensures Public Sector Access

Regulatory Update New Agreement on Health Supply Import Permits Ensures Public Sector Access

On December 4, 2024, an agreement was published in the Official Journal of the Federation (DOF), outlining the requirements for importing medicines and medical devices for the public sector. This agreement allows importing these products without a COFEPRIS sanitary registration, provided certain criteria are met. It aims to expedite supply processes, especially for consolidated purchases under BIRMEX scheme.

Understanding the Difference Between Advertising Notices and Permits

Understanding the Difference Between Advertising Notices and Permits

In Mexico, advertising of products and services for human use or consumption is regulated by COFEPRIS and requires an authorization that can be a notice or a permit, depending on the type of product or service. Both procedures are carried out in order to guarantee compliance with the corresponding regulatory framework, avoid sanctions, and ensure responsible advertising.