Mexican Registration Holder (MRH) Support

Your Path to Market Entry Excellence in Mexico

Medical device manufacturers without a presence in Mexico are required to appoint a Mexican Registration Holder (MRH), as per Regulatory requirements of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). As your MRH, Freyr ensures a smooth entry into the Mexican medical device market.

Mexican Registration Holder (MRH) Support Overview

A Mexican Registration Holder (MRH) is required to ensure compliance with COFEPRIS (the Federal Commission for Protection against Sanitary Risk) regulations governing the registration, quality, and Post-marketing Surveillance (PMS) of medical devices and other health-related products in Mexico.

Freyr Marketing Authorization Holder (MAH)/ Designated Marketing Authorization Holder (DMAH) Competencies:

    Medical device Regulatory experts at Freyr serve as liaisons between your company and the COFEPRIS.
    Assistance in compliance with COFEPRIS norms.
    Carry out product registration and CBPF certification.
    Assist in the renewal of device registrations.
    Maintaining and updating of license (as required).
    An expert and dedicated team to handle your Regulatory responsibilities.
    MRH will assist with the provision of your registration certificate issued by COFEPRIS.
    Provision of a single source for representation in Mexico from all the markets.

Frequently Asked Questions (FAQs)

  • The individual providing the Mexican Registration Holder services must be a resident or a legally established entity in Mexico.
  • The Mexican Registration Holder (MRH) or their legal representative in Mexico is required to submit necessary documents to the COFEPRIS (the Federal Commission for Protection against Sanitary Risk). This includes sanitary registrations and revisions and ensuring the product's quality and safety align with health registration standards.
  • The MRH acts as the primary liaison with Regulatory authorities and are accountable for any modifications or updates to the product's registration.

It is necessary to have a Mexican Registration Holder (MRH) as certain medical device businesses entering the Mexican market rely on distributors who also act as Registration Holders to expedite product approval and registration. Because the distributor has complete control over the registration, adding or changing distributors may be challenging.

If the distributors are moved, the current distributor (your Mexican Registration Holder) must grant the new distributor access to import devices. If the prior distributor is unable to cooperate, they must re-register the device to choose a new MRH.

  • MRH ensures compliance with Mexico's Regulatory requirements for product registration.
  • Manages the process of obtaining the Certificado de Buenas Prácticas de Fabricación (CBPF) certification from COFEPRIS.
  • Communicate with health authorities regarding product-related issues.
  • Updates COFEPRIS on any changes to medical device information.
  • Maintains product documentation for inspections.
  • Assumes legal responsibility for the product's quality.
  • Monitors renewal dates to ensure ongoing compliance with regulations.

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Why Freyr?

  • Independent Representation and Regulatory Support.
  • Continuous Liaison with the Agency for Submissions, Queries, and Feedback.
  • Single Point of Contact in the Country for Liaison with the Regulatory Agency.