Regulatory Certainty of Medical Devices in Mexico
The landscape of the Mexican medical device market is characterized not only by a surge in technological advancements and innovation, but also for its regulatory entry barriers. Therefore, to guarantee transparency and efficiency, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has devised a Regulatory Certainty Strategy for the Medical Device Sector that […]
Classification and Grouping of Bone Substitutes in Mexico
Bone substitutes, considered as medical devices, offer a wide range of products. Emerging from the necessity for treating a vital component of a patient’s body, the landscape of bone substitute materials and their applications has expanded to meet the growing demands of healthcare. In this article, we discuss different types of bone substitutes, as […]
Classification and Grouping of Laser Medical Devices in Mexico
The incorporation of laser technology to medical devices has come to play a crucial role in a diverse range of healthcare applications. Beyond their association with cosmetic procedures, many medical devices include lasers, transforming patient care and attention. From breaking down kidney stones to corneal correction, laser technology enhances healthcare and continues to evolve as […]
Classification and Grouping of Patient Monitoring Systems in Mexico
Patient monitoring systems nowadays offer an ample array of healthcare solutions. From clinical healthcare to personal use, healthcare monitors evolve to satisfy new needs, and so does their basic structure and components. This continuous state of evolution often constitutes a challenge when trying to classify and group them in the context of the Mexican regulatory […]
Classification and grouping of Mouthwashes as a Medical Device in Mexico
As discussed in our Classification and Grouping Ultimate Guide, the first step on classifying a product is to determine if it qualifies as a medical device in Mexico. A particular case is when products are considered Over the Counter Drugs or require a different type of licensing in other regions, but may fall under the medical […]
Classification of Software as a Medical Device in Mexico
As previously discussed in our article for Software as a Medical Device (SaMD), a significant development has occurred in the Mexican regulatory framework. The introduction of the first official approach to regulating SaMD marks a crucial step in the right direction, aiming to establish a faster and more comprehensive regulatory environment. However, the rapid […]
Authorization for the Acquisition and Transfer of Ionized Radiation Sources in Mexico
In Mexico, when registering medical devices related to Ionized Radiation Sources, there is a special subset of documents to be presented. The Authorization for the Acquisition and Transfer of Ionized Radiation Sources is one of these requirements. In this article, we provide a brief overview of this document within the context of the Mexican […]
Certificate to Foreign Government for Device Not Exported from the United States
As mentioned in our article about the Equivalency Agreement and our Ultimate Guide for Regulatory Affairs in Mexico, one of the choices you have to register a Medical Device for its sale and distribution in Mexico is the Equivalency Agreement route. In this regulatory pathway, one of the key documents for the FDA Equivalency route […]
