Instructions for Use and User Manuals for Medical Devices in Mexico
Instructions for Use (IFU) and user manuals are essential documents for any medical device. They ensure the safe and effective use of the device by providing clear, step-by-step guidance to healthcare professionals and/or patients. While these documents are standardized to a certain extent, there are specific requirements to keep in mind when registering such products […]
Understanding COFEPRIS Fees for Medical Device Registrations in Mexico
Entering the Mexican medical device market requires planning regulatory approvals and associated costs. A key aspect is understanding the fees charged by COFEPRIS and how the Marketing Authorization Holder (MHA) must cover them. This article breaks down those topics and outline important considerations for 2024. Legal Basis for Fees: COFEPRIS fees are established in […]
Medical Device Biocompatibility in Mexico: From ISO 10993 to COFEPRIS Requirements
As we have explored in a previous article about medical device standards, this medical device industry is extensive, and the regulations are just as vast. This time, we are diving a bit deeper into a crucial topic: Biocompatibility Studies. Here we will talk about ISO 10993, the standard for evaluating biocompatibility for medical devices and […]
Classification and Grouping of Glucometers in Mexico
Glucometers are essential devices for individuals suffering from diabetes. Part of a diverse array of devices that help diabetic persons to improve their quality of life, these compact devices provide quick and accurate readings, enabling users to make informed decisions about their diet, medication and overall health management. This article will discuss the characteristics […]
Electrical Testing Standards for medical electrical equipment and its use in Mexico
In a previous article, we have reviewed the regulations for medical electrical equipment (MEE) in Mexico and mentioned the cases when a medical electrical equipment needs to meet local standards. In this article we will review the applicability of a key series of international technical standards for medical electrical equipment, the IEC 60601. […]
Classification and Grouping for Urology Medical Devices in Mexico
When registering Medical Devices in Mexico, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 23 rules). You can find some examples of the classification and grouping criteria in our previous articles for: Orthopedic Implants Ultrasound Systems Medical Imaging In vitro Diagnostics Surgical instruments Though, […]
Classification and Grouping for Dental Resins in Mexico
In our Classification and Grouping Ultimate Guide, we have explained how to classify and group medical devices according to the 23 rules detailed in the Appendix II of the Supplement of medical devices of the Mexican Pharmacopeia (FEUM). In addition, we have also explained how to make use of those rules to classify and group specific medical […]
Changes on the Renewal Process for Medical Device Sanitary Registrations in Mexico
As a means to make regulatory processes more accessible and efficient to everyone in the medical device sector in Mexico, COFEPRIS started an upgrading strategy to turn to the digital approach when trying to submit information pertaining regulatory affairs. Thanks to this digitalization process, many of the old regulatory paths regarding the acquisition and upkeep […]
Low-Risk Medical Devices Requirements for Mexico
Obtaining the Sanitary Registration for a product in Mexico requires to consider different regulatory pathways. In knowledge of this circumstances, COFEPRIS made a distinction between products already widely recognized and sold in the market, giving that selection of products the title of Class I Low-Risk, as to reduce the regulatory hurdles in order to obtain […]
Explanatory letters for COFEPRIS
COFEPRIS provides a list of diverse requirements for Medical Devices that must be completed to obtain a sanitary registration in Mexico. Nevertheless, it is often hard for foreign manufacturers to fully comply with all of them. Some of the most common cases are: Documentation not elaborated by the manufacturer COFEPRIS requirements are specific for […]
