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 […]
