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 […]
Updates on the Equivalency Agreement for Medical Devices in Mexico
Last June the 22nd 2021, the Ministry of Health in Mexico released an update to the Equivalency Agreements that is applicable for Pharmaceuticals and Medical Devices. This Agreement also emphasizes the possibility to import medical devices in Mexico without a sanitary registration. In this document we will summarize the main facts related to medical […]
Regulation in Mexico for Medical Electrical Equipment
Medical electrical equipment (MEE) has their own requirements for safety and performance due to the nature of the electrical/electronic systems involved. In the case of Mexico, there are specific norms that may be applicable to MEEs in addition the sanitary requirements. Those norms are of special interest for new medical technologies involving Bluetooth, WiFi […]
