IPSNEWS
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
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.
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.
Import Permit: A key requirement for importing some medical devices into Mexico.
In Mexico, obtaining an import permit is an important step for importing medical devices. This document allows medical devices to enter the country and ensures compliance with health regulations.
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.
Industry Trends 2025
Dive into the medical device, cosmetic, and dietary supplement industry trends. We offer a look at what to expect during 2025.
Office hours holiday period
Updates regarding holiday business hours for IPS, COFEPRIS, and notary services.
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.
What is the significance of having an Operating License?
This license serves as an official notification to the health authority, outlining the activities, products, and/or services offered by the establishment. This process enables COFEPRIS to effectively exercise its sanitary control and surveillance functions.
Mexico’s Health Leaders Convene at French Healthcare Day
IPS proudly sponsored this event, which brought together health sector experts and government leaders to analyze the complexities of nutrition and diabetes in Mexico.