Mexico Registration Holder for IVD and Medical Device Companies

As the registration’s owner, the MRH is also legally responsible for regulatory activities to obtain and maintain your registration, such as:

• Submitting registration documentation on your behalf and communicating with COFEPRIS regarding the status of your registration application.  
• Ensuring your registration dossier includes all required documentation according to your device classification and registration pathway. 
• Maintaining a vigilance system to ensure post-market monitoring of your device performance; reporting any adverse events within the required timelines and fulfilling all vigilance requirements.  

Your MRH is a person/company located in Mexico that acts as a liaison between your company and the national competent authorities in Mexico. Some manufacturers designate a distributor as their MRH. However, there are disadvantages to this arrangement, even though it may seem like a convenient option. COFEPRIS allows multiple distributors and importers on a registration, but the MRH, as the owner of the registration, must approve them. If a distributor is also your MRH, there may be a conflict of interest when you need to add or change your distributor. While registrations can be transferred to a new MRH, a rights transfer requires cooperation of the existing MRH.   

You also need an MRH with the expertise and resources to ensure your compliance with all post-market regulatory requirements. Your MRH is obligated to proactively monitor your device’s safety and effectiveness to ensure it performs in accordance with its intended use. The MRH is also responsible for vigilance reporting of any serious adverse events and failure to do so can jeopardize regulatory standing with COFEPRIS. An independent representative focused on the responsibility of an MRH will have personnel and established vigilance processes and procedures to make sure you fulfill your post-market surveillance requirements.  

Maintain control of your COFEPRIS registrations

Our Mexico Registration Holder service gives you complete independence, allowing you to maintain control over your registrations without relying on distributors. You can add or change distributors without complications, so you can adapt to market changes swiftly.

Deliver comprehensive regulatory support

MedEnvoy has extensive experience with COFEPRIS’s medical device regulatory requirements. We provide end-to-end support from initial registration through post-approval activities, including regulatory compliance and modifications or updates. We can also expedite the registration process by leveraging third-party reviewers.

Handle all regulatory communication with COFEPRIS

As your MRH, MedEnvoy will be the main point of contact with COFEPRIS to ensure any issues are addressed quickly and in compliance with COFEPRIS requirements.