The Mexican market is complex and diverse, so it's essential to have a tailored strategy for each product.
IPS is a leading provider of regulatory services for the health industries in Mexico. We help manufacturers and distributors of medical devices, dietary supplements, and cosmetics navigate the complex Mexican regulatory landscape. Contact us today to learn more.
In commemoration of the 10th Anniversary of the College of Biomedical Engineers of Mexico (CIB), IPS spoke with Montserrat Godínez, President of this important institution. This interview delves into the organization's milestones, challenges, and future aspirations.
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.
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.