Regulatory Update
IPS
COFEPRIS: A Catalyst for Investment in Mexico

COFEPRIS is undergoing a significant transformation under "Plan México," aiming to become an agile, transparent, and internationally harmonized agency. This includes a push for 100% digitization of procedures, fostering clinical research, streamlining regulatory pathways, and modernizing the regulatory framework to boost investment and ensure public health.

COFEPRIS: A Catalyst for Investment in Mexico
Regulatory Update
IPS
Regulatory Update COFEPRIS simplifies ...

The simplification of procedures for the application of the advertising permit for products and services, as well as for health supplies, and for the export support certificate procedures, has been published.

Regulatory Update COFEPRIS simplifies Advertising & Export Permits
Regulatory Update
IPS
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
IPS
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
IPS
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
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The Importance of sharing updated documentation in Medical Device distribution

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The Importance of sharing updated documentation in Medical Device distribution

In the medical device sector, safety and regulatory compliance are fundamental to ensuring quality and protecting patients. A key aspect of this process is traceability within the supply chain. As distributors, sharing updated information, such as the Notice of Operation and the Registration of the Tecnovigilance Unit, with the sanitary registration holder is not only a regulatory obligation but also an essential practice to ensure operational continuity and avoid setbacks in procedures with COFEPRIS.

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.