Appointing an MRH
Selecting and appointing the right Mexico Registration Holder is a critical strategic decision. The MRH will hold your registrations and manage all regulatory interactions with COFEPRIS.
Legal requirements for the MRH entity
The MRH must:
- Be a legally constituted entity in Mexico (corporation, limited liability company, or individual with legal capacity to act commercially).
- Hold a valid Aviso de funcionamiento (notice of operation) from COFEPRIS.
- Designate a Responsable Sanitario (Health Manager) — a qualified professional registered with COFEPRIS.
- Demonstrate the ability to operate a technovigilance unit (personnel, procedures, systems).
Power of attorney (PoA)
The foreign manufacturer must provide the MRH with a poder notarial (notarised power of attorney):
- Executed before a Mexican notary public or apostilled if executed abroad.
- Granting the MRH authority to submit applications, hold registrations, manage renewals, and communicate with COFEPRIS on the manufacturer's behalf.
- Specifying the scope of authority (general regulatory representation or limited to specific devices/functions).
The PoA is a required document in every COFEPRIS submission.
Due diligence checklist
Before appointing an MRH, verify:
- Legal standing in Mexico — company registration (RFC / SAT records).
- Valid Aviso de funcionamiento from COFEPRIS.
- Nominated Responsable Sanitario with COFEPRIS credentials.
- Established technovigilance procedures and personnel.
- Experience with COFEPRIS registration and the relevant device category.
- References from existing manufacturing clients.
- Financial stability and business continuity.
- Clear contractual terms covering registration transfer rights.
Independent firm vs distributor model
| Model | Advantages | Disadvantages |
|---|---|---|
| Independent regulatory firm as MRH | Regulatory/commercial independence; flexibility to change distributors | Added cost layer; firm needs adequate technical knowledge of your device |
| Commercial distributor as MRH | Single point of contact; distributor already motivated to support registration | Changing distributors requires registration transfer — can take months; risk of disruption |
Most regulatory consultants recommend the independent firm model to protect long-term regulatory continuity.
Contractual protections
Your MRH agreement should include:
- Provisions for registration transfer — specifying timelines, cooperation obligations, and any exit fees.
- Intellectual property and confidentiality protections for your technical dossier.
- Clear definition of technovigilance responsibilities.
- Service level commitments for response to adverse events and COFEPRIS queries.
Related pages
Risk management: MRH Aviso de funcionamiento: If your MRH's Aviso de funcionamiento is revoked or lapses, your device registrations are at immediate risk of suspension or cancellation. Ensure your MRH agreement includes clauses requiring the MRH to notify you immediately of any regulatory action affecting their operational status. Establish a contingency plan to appoint a replacement MRH within 30 days if needed. Request proof of current Aviso de funcionamiento status from your MRH at least quarterly.