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 Endoscopes in Mexico

Classification and Grouping of Endoscopes in Mexico

Endoscopes are indispensable tools in modern medicine, allowing healthcare professionals to diagnose and treat conditions within the body with minimal invasiveness. With the recent advancements in medical technology, the range of endoscopic equipment has expanded significantly. This article provides an overview of the types of endoscopes, their applications, and the regulatory requirements for their classification […]

Classification and Grouping of Hospital Sterilizers in Mexico

In hospitals and medical facilities, ensuring the cleanliness and sterility of medical instruments and equipment is essential to patient safety and infection control. By applying the method known as sterilization, equipment is rid of all forms of microbial life, including bacteria, viruses, fungi, and spores. In this article, we will focus on the characteristics and […]

Pacemakers Classification and Grouping in Mexico

Pacemakers Classification and Grouping in Mexico

The pacemaker has been considered an important precursor of many developments in science and cardiac medicine, playing a unique role in managing heart rhythm disorders. Pacemakers can greatly improve the quality of life for individuals with heart rhythm disorders by reducing symptoms such as fatigue, dizziness, and fainting. They also help prevent serious complications associated […]

Defibrillators Classification and Grouping in Mexico

Defibrillators are considered a critical tool, not only for medical practitioners, but for anyone attempting to save a life from a cardiac arrest episode. The use of defibrillators is a crucial part of the chain of survival in cases of sudden cardiac arrest. Early defibrillation, along with cardiopulmonary resuscitation (CPR), can significantly increase the chances […]

Classification and Grouping of Balloon Catheters in Mexico

types of balloon catheters

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 […]

COFEPRIS Immediate Service Counter

The Mexican regulatory compliance landscape is constantly evolving. With the challenges faced during the recent pandemic, a need for agile and simplified processes was made evident. The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) took note of the situation, and based on the practical applications of other health agencies worldwide, a plan with […]

Technical Sessions

In the current landscape of Mexican regulatory compliance, the opportunity for an open dialogue with the health agencies is a great asset. In order to strengthen communication channels between the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the regulated sector, a new mechanism known as Technical Sessions has come into play. This […]

Regulatory Certainty of Medical Devices in Mexico

The landscape of the Mexican medical device market is characterized not only by a surge in technological advancements and innovation, but also for its regulatory entry barriers. Therefore, to guarantee transparency and efficiency, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has devised a Regulatory Certainty Strategy for the Medical Device Sector that […]

Classification and Grouping of Bone Substitutes in Mexico

Bone substitutes, considered as medical devices, offer a wide range of products. Emerging from the necessity for treating a vital component of a patient’s body, the landscape of bone substitute materials and their applications has expanded to meet the growing demands of healthcare.   In this article, we discuss different types of bone substitutes, as […]