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.