Ion Gel ZCM-25® has officially received COFEPRIS regulatory approval in Mexico as a Class 2 Medical Device, marking a significant step forward in wound treatment and infection prevention. Developed by Ion Biotechnology México, S.A. de C.V., this innovative topical gel is designed for medical settings ranging from surgical recovery to chronic wound care.
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the national health authority in Mexico responsible for regulating medical devices, pharmaceuticals, and public health risks. Its approval indicates that Ion Gel ZCM-25® has undergone the necessary scientific, safety, and technical evaluations to meet national standards for use in medical settings.
As a Class 2 Medical Device, Ion Gel ZCM-25® is recognized for its moderate-risk profile, typically requiring a higher level of quality assurance than Class 1 products. This classification is commonly assigned to products with therapeutic benefits, particularly those intended for wound management, infection prevention, and post-surgical recovery, which align perfectly with the gel’s clinical applications.
Ion Gel ZCM-25® is formulated with IBAL (Ion Biotechnology Aqueous Ligands) technology, a proprietary system developed by Grupo Ion Biotech that combines essential cations such as zinc, copper, magnesium, sulfur, and hydrogen in a redox-active, bioavailable gel. This multi-ion formulation has been shown to deliver a range of therapeutic effects, including:
These properties make the gel especially suitable for diabetic foot ulcers, surgical site recovery, and chronic wound treatment—key challenges in modern healthcare in public and private settings.
To meet growing demand and regulatory quality standards, Ion Biotechnology México has partnered with Manuel Laboratory, a reputable pharmaceutical-grade production facility based in Mexico City. This collaboration ensures that production-scale batch testing is conducted under Good Manufacturing Practices (GMP), a critical step in commercial readiness and clinical scalability.
The lab’s role includes rigorous quality control, sterility testing, and batch validation, ensuring that every tube of Ion Gel ZCM-25® delivers consistent efficacy, safety, and shelf stability. This local partnership also represents a significant investment in Mexico’s health innovation infrastructure, supporting national capacity for advanced biomedical manufacturing.
With regulatory approval now secured, Ion Biotechnology México is preparing to launch Ion Gel ZCM-25® into the Mexican healthcare market starting early 2022.
By positioning Ion Gel ZCM-25® within clinical and consumer health channels, the company aims to address the growing demand for cost-effective, science-backed topical solutions amid rising concern over antimicrobial resistance (AMR) and healthcare-associated infections (HAIs).
The regulatory approval of Ion Gel ZCM-25® is more than a commercial milestone; it reflects a scientific commitment to healing through innovation. Built on over a decade of molecular research and clinical insight, the product exemplifies the potential of ion-based therapies in tackling some of the most persistent problems in modern medicine.
With the support of COFEPRIS, a trusted laboratory partner, and a clear market entry strategy, Ion Biotechnology México is poised to deliver a next-generation solution for wound healing that is safe, accessible, and grounded in biological science.
As Mexico enters a new era of preventive and regenerative medicine, Ion Gel ZCM-25® stands as a pioneering tool for professionals seeking faster recoveries, lower infection risks, and improved patient outcomes—all packaged in a powerful, transparent 10g tube.