IPSNEWS
Innovation, Regulation, and Collaboration: A 10th Anniversary Interview with the CIB
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.
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 proposes changes to NOM-240: Responsibilities for Manufacturers and Distributors (Updated)
The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities. Public feedback is welcome to evaluate the impact of the proposed changes.