Classification and Grouping for Laryngoscopes and Video Laryngoscopes (Mexico)
Laryngoscopes are essential medical devices used in anesthesiology and airway management. While traditional laryngoscopes have been in use for many years, advancements in technology have led to the development of video laryngoscopes. These innovative devices involve additional considerations for their sanitary requirements in Mexico. Types of Laryngoscopes Classic or Conventional Laryngoscopes: consist of […]
Hygienic Products as Medical Devices in Mexico
Hygienic products, typically thought of as substances for personal cleanliness, hold a unique position in Mexico’s regulatory landscape. Classified as medical devices, these products fall under the scope of COFEPRIS, requiring sanitary registration to be commercialized in the country. In this article, we briefly describe the characteristics and regulatory requirements surrounding these products. Defining […]
Clinical Evaluation Studies for Medical Device Approval in Mexico
Clinical evaluation for medical devices is critical because it provides the scientific evidence to demonstrate that devices are safe and effective for use in real-world situations. For sanitary registration purposes in Mexico, is acceptable to submit clinical trials performed in this country or abroad. However, there are other ways to fulfill the clinical evaluation requirements. […]
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 […]
Colposcopes Classification and Grouping in Mexico
Colposcopes are indispensable tools in gynecological examinations, significantly contributing to the early detection and treatment of cervical and other genital abnormalities. This medical device is crucial for diagnosing various conditions, including cervical cancer and other abnormalities. In this article, we analyze the components and applications of colposcopes, as well as provide general criteria for their […]
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 […]
Classification and Grouping of Balloon Catheters in Mexico
Balloon Catheters stand as precise instruments in the array of medical devices. Employed to alleviate obstructions and stenosis across various bodily systems, they are a great exemplification of controlled intervention. In this article, we will discuss the structure, diverse applications, and existing types of Balloon Catheters. Additionally, we will review general guidelines on their classification […]
Technovigilance for Medical Devices in Mexico
Introduction Technovigilance or Medical Device Surveillance is the activity that guarantees that any medical technology in Mexico is correctly working and describes how to report any incident related to the device. In this text, we summarize the technovigilance requirements in Mexico. Specifically: How to identify an adverse incident, When to report and not report […]
