Holding Structure and Registration Holder Design in Mexico

1. Key takeaways

The compliance structure in Mexico is built from three parties: the foreign manufacturer as the source of technology and evidence, the registration holder (MRH) as the legal registration subject and the tecnovigilancia subject, and the importer / distributor as the party handling customs clearance and the sales channel. Setting the holder up as a compliance entity that is independent of the commercial channel is the key design decision for reducing transfer risk and retaining control over the registration. Where the holder is a subsidiary of the distributor, the manufacturer’s access to its own registration history depends entirely on the health of that relationship, which is the risk the independent design exists to remove.

• The structure has three parties with distinct legal roles, and none of them can absorb another’s duties.
• The manufacturer appears in the evidence, not in the registration record.
• The holder owns registration, platform account, vigilance, recall execution, changes, and renewal.
• Importers can be added or changed under one registration without touching the registration itself.
• Three core agreements form the skeleton, and their completeness determines structural stability.

2. Legal basis

The allocation of roles is not a commercial preference but a consequence of specific provisions: the regulation requires the manufacturer’s letter where manufacture is not by a parent company, the vigilance NOM places the unit on the holder, the labelling standard shares intended-use responsibility between holder and manufacturer, and the import permit is filed by defined subjects. Each provision also implies a contract term, so the agreement set should be drafted against this table rather than against a generic template. The table below lists each source.

3. Expert insights

Insight one: the manufacturer’s legal role is that of an evidence provider. The manufacturer issues the authorised representative letter, the CFS, the GMP certificate, and the certificates of analysis, but the registration certificate does not record its name. Its influence therefore rests on contract, not on registration records, and every right the manufacturer needs must be written into an agreement to be enforceable. Evidence obligations should likewise be timed in the contract, since late certificates delay filings as surely as missing files do.

Insight two: the holder is the responsible subject. Registration, the platform account, the tecnovigilancia unit, recall execution, changes, and renewal are all carried out in the holder’s name. In addition, NOM-137-SSA1-2025 requires the holder to participate in defining the intended use on the label and in reviewing the instructions for use, so the holder’s duties reach into technical content, not only into filings. This also means the holder needs qualified staff or advisors who can actually review intended-use statements rather than only submit them.

Insight three: the importer is the customs and channel party and can be separate from the holder. Multiple importers can be added under a single registration, and the registration itself does not have to become part of the channel arrangement. This leaves room for adjusting the commercial channel without touching the regulatory structure, which is precisely the flexibility the independent holder design is meant to protect. Companies should map their importers against the registration record at least annually to keep that flexibility usable.

Insight four: three core documents form the structural skeleton. The authorisation and responsibility agreement between manufacturer and holder, the import and vigilance notification agreement between holder and importer, and the technical support and data access agreement from manufacturer to holder. The completeness of these three documents determines the stability of the structure, and any gap becomes a dispute the moment the commercial relationship changes. Reviewing the three agreements together, rather than one at a time, is the only way to see whether duties overlap or fall through between them.

Insight five: the value of the structure appears at exit. While the cooperation runs smoothly, structural design makes no visible difference. Once a channel change or a breakdown in the relationship occurs, the independent holding arrangement preserves market access, and it is exactly at that moment that the cost of having structured properly is repaid. Exiting parties should also verify that the replacement clauses agreed in advance are complete enough to execute without renewed negotiation.

4. Practical recommendations

• Keep the holder independent of the commercial channel, and do not change the holder when the channel changes.
• Write eight items into the authorised representative letter and the responsibility agreement: application, payment of fees, responses to inquiries, document retention, vigilance, recall, changes, and renewal, each with the responsible party named.
• Agree with importers on the escalation path and internal time limits for vigilance information, back-calculated from the 2 working days / 10 days / 30 days tiers.
• The manufacturer retains ownership of technical files and data access, while the holder retains the right to use and retain them to meet regulatory needs.
• Preset in the agreement the trigger conditions for replacing the holder, the cooperation duties, the time limits, and the cost allocation (at the 50% level of the registration fee).

5. Verification checklist

• □ The holder is independent of the commercial channel
• □ The authorisation and responsibility agreement covers the eight duties
• □ The importer’s vigilance notification path and time limits are agreed
• □ Ownership of technical files and data access rights are agreed
• □ Holder replacement clauses are preset (including 50% cost allocation)
• □ The one-registration-multiple-importers mechanism has been taken up

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Mexican market. Our team manages COFEPRIS registrations and equivalence (equivalencia) reviews, coordinates third-party authorised centre routes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com