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
Content Update & Historical Note: This article reflects the regulatory framework as it stood in June 2021 and is retained for historical context and tracking the evolution of Mexican regulations. Since this publication, the framework has been significantly updated. For the most current, authoritative, and expanded list of recognized regulatory authorities, we strongly recommend reading […]
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 […]
Classification and Grouping for Ultrasound systems 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 […]
What COFEPRIS requires for the Certificate of Free Sale.
The Certificate of Free Sale (CFS), also known as “Certificate for Export” or “Certificate to Foreign Government”, is a document to evidence that goods, such as medical devices, are legally sold or distributed without restriction. Ministries of Health from different countries require a Certificate of Free Sale as part of their regulatory evaluation. In […]
New amendments in the regulation for Medical Devices in Mexico
Last May the 31st 2021, the Ministry of Health in Mexico released an update to the Health Supplies Regulation. There are several amendments impacting different health supplies and in this document we will present a summary for those affecting Medical Devices: Translations Before this announcement, the Ministry of Health required that any submission […]
Software as a Medical Device (USA, Europe, Canada and Mexico cases)
Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis of clinical conditions and diseases. Even when software has been included as part of medical devices, in recent years it has been an increased use of software as a medical device by its own. This […]
About the regulation of previously owned medical devices in Mexico
The market of previously owned medical devices in Mexico works in different business models and therefore, arises questions about its regulatory requirements. For instance, public hospitals in Mexico are not allowed to buy previously owned medical equipment, but they can accept them by donation. It is also well known that used, refurbished or remanufactured medical […]