Mexico Medical Device Registration Holder (MRH): Rules for the Titular

1. Key takeaways

In Mexico, the registration holder — often described as the Marketing Registration Holder, or MRH — is the entity formally named on the health registration certificate as the titular. This entity must be a legal entity established in Mexico; a foreign manufacturer cannot hold the registration in its own name. The holder carries at least seven core obligations: submitting the registration application, paying the official fees, receiving and responding to official enquiries from the authorities, keeping the complete technical dossier locally in Mexico, reporting under the medical device vigilance system, managing recalls, and handling amendments and renewals of the registration. Because all of these duties sit with the Mexican titular, the choice of holder is a structural compliance decision rather than a simple administrative formality. Manufacturers that treat it casually often discover later that they cannot control their own market access.

• The registration holder must be a legal entity established in Mexico; foreign manufacturers cannot self-hold.
• The holder carries at least seven obligations, from application and fee payment through vigilance reporting, recalls, amendments and renewals.
• Official submissions, fee payments, responses to enquiries, deficiencies, amendments and renewals can only be executed in the name of the holder.
• Platform access is tied to Mexican tax registration, which naturally anchors every procedure to a local entity.
• Under the current labelling standard, the holder must be substantively involved in labelling and instructions for use, and can no longer be a purely nominal party.

2. Legal basis

The duties of the Mexican registration holder are not drawn from a single provision. They are spread across the medical devices regulation, the technical vigilance standard, the labelling standard and the General Health Law as amended in 2026. The table below summarises the four instruments that together define who the holder is and what the holder must do.

3. Expert insights

Insight one: the obligations rest with the holder, not the manufacturer. Section 6.7.1 of NOM-240-SSA1-2012 places the duty to establish a technical vigilance unit, to designate the responsible professional, and to notify COFEPRIS of that designation in writing squarely on the registration holder. Distributors carry only a secondary obligation to report incidents to the holder. In practical terms this means that a manufacturer located outside Mexico cannot simply assume that its own quality system satisfies Mexican vigilance duties; the local entity named on the certificate is the one the regulator will hold to account, and the manufacturer’s internal processes only matter to the extent the holder can rely on them.

Insight two: the requirement applies to all risk classes, including Class I. The technical vigilance unit requirement covers every registered device. There is no exemption based on risk classification, so a low-risk Class I product carries the same structural demand for a local vigilance function as a Class III device. Manufacturers planning a Class I portfolio should not assume that simplification at the registration stage translates into lighter duties after the device is on the market; once the registration exists, the vigilance framework attaches to it in full.

Insight three: the 2025 labelling standard expands holder responsibility. NOM-137-SSA1-2025 requires the holder to share with the manufacturer the responsibility for defining the intended use on the label, and to participate in the development and review of the instructions for use. The holder is no longer a nominal party that merely lends its name to the certificate. For manufacturers, this changes what a holder relationship must look like in practice: the holder needs the technical capacity to review intended use statements and labelling content, which in turn should influence how a manufacturer selects and supports its titular.

Insight four: platform access is inherently tied to a local entity. DIGIPRiS is accessed using an e.firma / FIEL, the electronic signature issued by the tax administration to registered taxpayers. Without a Mexican tax registration there is no platform account, and without a platform account there is no way to submit procedures directly. This is one of the most concrete reasons why the holder must be a Mexican entity: the gatekeeping mechanism of the entire regulatory workflow is rooted in the national tax system rather than in the health sector itself.

Insight five: every registration-related action can only be performed by the holder. Applications, fee payments, collecting official responses, answering deficiencies, amendments and renewals — all of these are executed in the name of the holder. A manufacturer’s coordination capability cannot directly substitute for the holder’s legal standing. Even where a manufacturer manages the project end to end, each formal step must be routed through the titular, which makes the responsiveness and reliability of the holder a genuine operational variable rather than a legal abstraction.

4. Practical recommendations

• When selecting a holder, assess its capability against each of the seven obligations individually, with particular attention to technical vigilance and platform operation, since these two areas drive most day-to-day interaction with the authorities.
• Record the authorisation arrangement in a written agreement that sets out the division of responsibilities and the timelines between the parties on vigilance, recalls, amendments and renewals, so that operational expectations are enforceable rather than informal.
• Maintain one complete copy of the technical dossier locally in Mexico, so the holder can retrieve it at any time to respond to electronic verification under Article 396, item I, of the LGS.
• Ensure the holder substantively participates in the review of labelling and instructions for use, so the joint responsibility created by NOM-137-SSA1-2025 is genuinely discharged rather than left on paper.
• Establish holder KPIs — deficiency response time, vigilance reporting timeliness, and the lead time maintained for renewals — and review them annually as part of supplier and partner oversight.

5. Verification checklist

• □ The holder is a legal entity established in Mexico
• □ The seven obligations are recorded in a written agreement
• □ The technical vigilance unit is established and the responsible professional has been notified to COFEPRIS in writing
• □ The complete technical dossier is retained locally in Mexico
• □ The holder has participated in the review of labelling and instructions for use
• □ Holder KPIs have been established

Regulatory information verified as of October 28, 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