Mexico Authorized Representative (AR)

Foreign manufacturers that wish to market medical devices in Mexico are required to appoint a local Authorized Representative, also known as a Mexico Registration Holder (MRH). This legal representative must be a legally established company or entity with permanent residence in Mexico. The Mexico Registration Holder acts as your primary liaison with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) - the division within the Mexican Ministry of Health responsible for medical device oversight. 

Choosing a commercial partner as your Registration Holder offers strategic advantages. It allows you to assign or replace local distributors without being dependent on a single party. Moreover, it ensures you have a reliable local presence to manage and protect your sanitary authorizations effectively.

The medical device registration process can follow two review pathways: the standard review averaging about 12 months, and an accelerated third-party review taking 3 to 6 months. Devices previously approved in recognized countries like the US, Canada, Japan, or the EU may benefit from expedited review or streamlined registration.

Liaison with COFEPRIS

The MRH acts as your official point of contact with COFEPRIS, and is responsible for acting on behalf of the manufacturer in all regulatory communications. This includes responding to authority queries and facilitating inspections or audits. The MRH represents the manufacturer for all regulatory inspections, and legal matters.

Registration & documentation

The MRH is responsible for managing and submitting all medical device and IVD registration applications to COFEPRIS. This includes compiling technical documentation, ensuring proper classification, and preparing submission (renewal) dossiers in accordance with Mexican regulatory requirements. The MRH also handles application tracking, deficiency responses, and updates throughout the product lifecycle.

Compliance

Beyond initial registration, the MRH ensures that all devices placed on the Mexican market comply with applicable Mexico Medical Device Regulations and standards. This includes verifying labelling requirements (in Spanish), maintaining regulatory documentation, and ensuring adherence to local quality and safety standards. The MRH is responsible for sanitary compliance and may require personnel with pharmaceutical, biomedical, or regulatory expertise. The MRH also oversees post-market compliance activities such as complaint handling, and corrective actions when necessary.

Technovigilance

Another responsibility of the MRH is managing technovigilance activities in line with COFEPRIS requirements. This includes the systematic monitoring of device performance in the market (PMS), collection and evaluation of adverse events, and timely reporting to COFEPRIS. The MRH is also responsible for coordinating field safety corrective actions (FSCA), recalls if required, and maintaining detailed vigilance records.

Importantion checks & distribution control

The MRH ensures that all importation activities are aligned with regulatory approvals and COFEPRIS requirements. This includes verifying device authorization for, accurate documentation and necessary sanitary licenses for import. The MRH also maintains oversight of distribution channels and ensures traceability.