Classification and grouping of face masks in Mexico
Face masks consist in a protective covering for the mouth and nose. They are usually made from non-woven fabric and designed to avoid spreading infectious microorganisms, such as viruses and bacteria. In regulatory terms, there are different types of face masks that also differ in their classification. In Mexico, we can define three classifications […]
Regulatory requirements for medical device clinical trials in Mexico
A clinical trial for medical devices can be defined as a systematic research or study in humans, conducted to evaluate the safety or performance of the product. Mexico can be an interesting country to perform such clinical trials, not only because of the lower costs and reduced timelines compared with other nations, but the great […]
COFEPRIS keeps its digitalization process through DIGIPRis
As reported last September 2020, COFEPRIS has kept its digitalization strategy with the solid conviction to optimize the approval process for both medical devices and pharmaceutics. In this stage, COFEPRIS announced the platform DIGIPRiS. In this article, we will describe more details about how this digital alternative works and for which regulatory processes is applicable. […]
Classification and regulation of sanitizers in Mexico
Sanitizers in regulatory terms are complex products. In some countries, they are classified as cleaning products, cosmetics or biocides. In addition, their sanitary authorization is not required in all countries. This is the case for Mexico, in which sanitizers can be classified as medical devices or require to comply with Mexican Norms. In this article […]
Classification and Grouping for Dialysis machines and accessories in Mexico
Bringing hemodialysis technology to the Mexican market requires a strategic look at how dialysis machines and their specialized accessories (such as dialyzers, tubing, and needles) interact under COFEPRIS regulations. While these devices must adhere to Mexico’s general classification criteria, the complexity of dialysis systems creates unique challenges for manufacturers during the COFEPRIS submission process. In this guide, we move […]
Low risk and non-regulated medical devices
Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the Ministry of Health categorizes medical devices as Class I, II, or III. Additionally, there is a sub-group known as Class I Low Risk, which is not a separate fourth class, […]
When and how to choose a Medical Device Distributor in Mexico
Based on our databases, Mexico has more than 2,000 distributors with at least one Sanitary Registration (including Holding companies) and over 100 distributors managing more than one hundred registrations each. If we consider the full ecosystem, the universe surpasses 5,000 entities. However, estimating the exact number of sub‑distributors is challenging because they do not appear in […]
Good Manufacturing Practices certificate issued by COFEPRIS
In a previous article, we talked about the Good Manufacturing Practices (GMPs) certificates that can be used in Mexico. This certificate is broadly used in the Medical Device Industry, and it is a way to demonstrate that processes are followed to guarantee the quality of the product. In this document, we will discuss about […]
Classification and Grouping for Stents in Mexico
As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM). In this article we will focus on explaining strategies to classify and group […]
Certificate of Free Sales issued by COFEPRIS and requirements
In a previous article, we explained what a Certificate of Free Sale (CFS) is, and the requirements of COFEPRIS for this document when issued abroad. As a side note, this document can also be known as Free Sales Certificate (FSC), Certificate of Foreign Government (for the case of the US FDA) and other similar names. […]