Regulatory Update
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Regulatory Update Mexico updates regulations ...

In Mexico, the Official Mexican Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, has been published, updating the previous version issued in 2021. This modification, in addition to providing more explicit guidelines, aims to enhance regulatory alignment at the international level.

Regulatory Update Mexico updates regulations with NOM-241-SSA1-2025
Regulatory Update
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Regulatory Update COFEPRIS Issues New ...

On March 20th of this year, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) published the Guidelines that define the requirements for Certificates of Good Manufacturing Practices (GMP) or equivalent documents, necessary for sanitary registrations, renewals, and modifications.

Regulatory Update COFEPRIS Issues New Guidelines for certificate Good Manufacturing Practices
Regulatory Update
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Regulatory Update COFEPRIS Simplifies Sanitary ...

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.

Regulatory Update COFEPRIS Simplifies Sanitary Procedures
Regulatory Update
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Regulatory Update Self-Verification Guide for ...

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 Self-Verification Guide for cosmetics establishments
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Josué Garza
Industry Trends 2025

Dive into the medical device, cosmetic, and dietary supplement industry trends. We offer a look at what to expect during 2025.

Industry Trends 2025

Health Supplies

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.

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.

Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

In 2020, Mexico implemented an agreement allowing expedited importation and equivalence of certain health supplies approved by recognized international regulatory bodies, aiming to address shortages and streamline access. However, an update in September 2024 nullified this agreement, requiring full compliance with Mexican regulatory processes for all health supplies.