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

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 […]

Low risk and non-regulated medical devices

Considering the broad type of products within the medical device sector, it is necessary to differentiate them depending on its level of risk. In Mexico, the sanitary authorities identifies them as Class I, II, III devices but also as Class I low risk, which is not a 4th class, but a sub-group of class I […]

When and how to choose a Medical Device Distributor in Mexico

Based on our databases, Mexico has +2,000 distributors with more than one Sanitary Registration (including Holding companies) and +100 owning more than one hundred. From all that universe of distributors (+5,000), it is difficult to estimate the sub-distribution, since none of them are considered in public databases.   Considering the number of distributors with sanitary […]

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. […]

COFEPRIS alternatives to expedite delayed submissions

Last August 13th 2021, COFEPRIS announced a new version of the so called ECAR program. This is basically an initiative from the authority to minimize the backlogged Medical Device applications. The main drawback is that the deadline to apply for it was August 20th 2021. Even though this alternative has expired, it is expected to […]

Classification and Grouping for Medical Imaging Systems in Mexico

As mentioned in our Classification and Grouping Ultimate Guide, there is a set of rules to classify and group medical devices in Mexico. Those rules are explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM).   We have already reviewed strategies to classify and group orthopedic implants, ultrasound systems and in […]

Classification and Grouping for In-Vitro Diagnostics 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 […]