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Navigating Medical Device Registration in Mexico:
A Pathway to Market Expansion and Life-Saving Impact

By Karla Hernandez

Mexico has a growing population of over 120 million people and a rapidly expanding healthcare system. Mexico’s market for medical devices is also booming, with a projected revenue of US$6.38B in 2023. Entering Mexico’s mercado de dispositivos médicos or medical device market can also translate to increased revenue, market growth and diversification for your medical device company. However, to market and sell medical devices in Mexico, registration seekers must navigate a complex regulatory system for medical device registration.

 

In Mexico, medical device registration and authorization is overseen by the Federal Commission for Protection against Health Risks (COFEPRIS), which is responsible for ensuring the safety and efficacy of medical devices sold in the country. The registration process beings with classifying your medical device. COFEPRIS separates medical devices into six families based on purpose and function. The families of medical devices include:


• Medical equipment

• Prosthetics, orthotics and functional aids


• Diagnostic devices

• Dental devices 

• Surgical materials 

• Hygiene Devices 

The medical devices are then classified based on risk, that is, any risk the medical device presents to the patient and/or user. Similar to the U.S. Food and Drug Administration (FDA), COFEPRIS has three classes, Class I, Class II and Class III, with Class I presenting the lowest risk. The following is a brief description of class:

• Class I: Low-risk devices that are not intended to enter the body, such as crutches or walking aids.

• Class II: Medium-risk devices that are intended to enter the body but do not penetrate the skin, such as thermometers or endoscopes.

• Class III: High-risk devices that are intended to penetrate the skin or come into contact with bodily fluids, such as implants or surgical instruments.

The classification of a medical device will determine the level of scrutiny it receives during the registration process. Class III devices will require a more rigorous review process than Class I or Class II devices. Following the classification of your device comes the registration process. This process involves an evaluation of the medical device to determine if it is equivalent to devices that are already registered in Mexico and/or if it meets the applicable standards in Mexico. This process can be broken down into two main pathways: the Equivalency review process and the Standard review process.

 

The Equivalency review process is designed for medical devices that have already been cleared by a regulatory body in another country. The devices previously cleared by the U.S. FDA, Health Canada and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are eligible for the Equivalency review process.

The Equivalency review process can be beneficial to reducing the timeline of the review process and requires less documentation within the medical device’s dossier.

 

The Standard review process is intended for medical devices that do not meet the Equivalency review process criteria and/or are new to the market. This process requires a more in-depth dossier of the medical device’s technical information and involves a more comprehensive evaluation of the device’s safety and efficacy.

 

In both instances, Equivalency and Standard review process, COFEPRIS will evaluate the medical device’s safety, effectiveness, and quality as well as any clinical data supporting the medical device’s use. A third-party review is an optional step in the medical device registration process in Mexico. Companies may choose to have their medical devices reviewed by a third-party organization to expedite the review process. However, it is important to note that COFEPRIS will still conduct its own review of the medical device, and the third-party review does not guarantee approval.

 

There is an additional and required factor for registration seekers who are not Mexico residents, this involves appointing a Mexico Registration Holder (MRH). The MRH is a legal entity established in Mexico, that acts as a legal representative for the medical device company and facilitates the registration process with COFEPRIS. The MRH is responsible for submitting the registration application and serving as the point of contact for COFEPRIS. The MRH is also responsible for maintaining registration and compliance with COFEPRIS regulations.

 

Regardless of which review process is chosen, the registration process can take multiple months to complete. It is also important to be aware of reporting requirements and post market surveillance activities that will be essential to ensuring that the medical device remains in compliance with Mexican regulations.

 

An additional important aspect of medical device registration in Mexico, is the fee associated with registration. The fee for medical device registration with COFEPRIS varies depending on the type of device and the registration process. The fee structure is based on a set of guidelines issued by COFEPRIS, which outlines the fees for each type of medical device, the associated services and the level of risk associated with the device. For example, the fees for Class I devices are generally lower than those for Class II or III devices, as they pose a lower risk to patients.

 

Overall, the cost of medical device registration with COFEPRIS can vary widely depending on the complexity of the device, the level of risk associated with it, and the services required for registration. Overall, medical device registration in Mexico can be a rigorous and complex process however, the registration pathway can be successfully navigated with thorough planning and meticulous attention to detail. Achieving registration can bring your company market expansion and more importantly, bring lifesaving medical technologies to patients who need them in Mexico.

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