What is a Mexico Registration Holder (MRH)?
The Mexico Registration Holder (MRH) is a legally constituted Mexican entity that holds COFEPRIS sanitary registrations on behalf of a foreign medical device manufacturer. The MRH role is mandatory for all foreign manufacturers seeking to market medical devices in Mexico.
COFEPRIS requires a legally accountable entity within Mexico for each registered device. Foreign manufacturers cannot directly hold a Mexican sanitary registration — the MRH bridges this gap, taking on full regulatory responsibility in Mexico.
Core function
The MRH:
- Owns the sanitary registration in Mexico — the registration is issued in the MRH's name.
- Serves as the official point of contact with COFEPRIS for all matters related to the registered device.
- Is legally responsible for regulatory compliance in Mexico.
- Manages technovigilance reporting to CNFV on behalf of the foreign manufacturer.
MRH vs Authorised Representative
| Aspect | MRH (Mexico) | EU Authorised Representative / UK UKRP / others |
|---|---|---|
| Holds registration? | Yes | No — manufacturer holds the authorisation |
| Legal accountability | Full regulatory ownership | Representative role only |
| Can be changed? | Yes — formal transfer required | Yes — notification process |
| Who holds the rights? | The MRH entity | The manufacturer |
The MRH model is unique to Mexico and Latin America. In most other major regulatory systems (EU, US, Australia), the foreign manufacturer holds the authorisation directly, with the local representative having a supporting role. In Mexico, the MRH is the registered holder, which has significant implications for distributor relationships and registration continuity.
Who can be an MRH?
- A legally constituted Mexican entity (company or individual with legal capacity).
- Must hold a valid Aviso de funcionamiento (notice of operation) from COFEPRIS.
- Must establish and operate a technovigilance unit.
- Must have a named Responsable Sanitario (Health Manager).
- Must hold a power of attorney from the foreign manufacturer.
The independent firm vs distributor dilemma
Many manufacturers appoint their commercial distributor as MRH for convenience. However:
- If you later wish to change distributors, you must also transfer your registrations — a process that can take months and may disrupt market access.
- Using an independent regulatory consulting firm as your MRH decouples your regulatory and commercial relationships, giving you flexibility.
Changing MRH is a formal COFEPRIS transfer process. The registration remains with the MRH entity until transfer is complete. Plan your MRH structure carefully before committing.
Related pages
The independent firm vs distributor dilemma
Technical dossier ownership & retention A critical issue when transitioning MRH: Who owns the technical dossier?
The manufacturer remains the source of truth — the original technical documentation (quality system records, clinical data, design files) remains the intellectual property of the foreign manufacturer. The MRH holds a copy for regulatory purposes — The MRH maintains a copy of the technical dossier submitted to COFEPRIS and uses it to support registration maintenance, renewals, and regulatory inquiries. Upon exit, the old MRH must transfer all copies of the regulatory dossier to the new MRH — This is a contractual and regulatory obligation. Failure to do so can block the transfer process and delay market access. Contractual protection:
Your MRH agreement should explicitly state that the technical dossier is held in trust for the manufacturer and must be surrendered upon termination without claim of ownership. Specify format (electronic or hardcopy), completeness requirements, and a defined transfer timeline (e.g., within 5 business days of termination notice). Include a escrow or third-party holding arrangement if you anticipate a contentious relationship. Disputes over dossier ownership — If the outgoing MRH refuses to transfer the dossier, COFEPRIS can become involved, but this significantly delays the MRH transfer process. Protect yourself contractually from the outset.