Mexico COFEPRIS Medical Device Registration: MRH, Reliance Route and Spanish Labelling

Mexico is one of the biggest medical device markets in Latin America, and it has been changing fast. The regulator, COFEPRIS (the Federal Commission for the Protection against Sanitary Risk), requires a sanitary registration for devices placed on the Mexican market, and recent reforms have added reliance and abbreviated routes for devices already approved by major regulators. This guide explains the standard process, the faster routes, the role of the Mexican registration holder and the labelling and quality system points that commonly slow projects down.

Classification and the standard route

Mexico groups devices into risk classes I to III, and class affects the dossier and the review time. A standard registration involves a full technical dossier submitted by the MRH.

Class	Risk	Dossier
I	Low	Shorter dossier, mainly descriptive and quality information
II	Moderate	Full technical dossier with performance and safety evidence
III	High	Full dossier with clinical evidence

Review times are commonly quoted in weeks for Class I and II and in months for Class III, but they vary with COFEPRIS workload and dossier quality. For the comparison of class systems see device classification.

The reliance and abbreviated routes

In 2025 COFEPRIS published an agreement that allows an equivalence (reliance) route for devices already authorised by reference regulatory authorities, including regulators represented on the IMDRF management committee such as the FDA, Health Canada and Japan. The reported target review time for the equivalence route is about 30 working days. Important points:

• It is not automatic approval. COFEPRIS still decides, and the product must meet the conditions of the route.
• You still need an MRH, Spanish labelling, translated and legalised documents and quality system evidence.
• Eligibility depends on the device category and on which authority granted the reference approval, and the rules are still being applied in practice, so confirm with the MRH before you plan around the route.

The Mexican registration holder

The MRH holds the registration in Mexico and acts for the manufacturer in submissions, renewals and incident reporting. Many foreign companies use a distributor or a specialist provider. The contract should cover ownership of the registration, document access, change notification and the transfer process if you change MRH.

Quality system and labelling

• Quality system: Mexican good manufacturing practice for devices is set out in the national standard NOM-241-SSA1. Evidence such as ISO 13485, an MDSAP report or an equivalent certificate is normally expected. See ISO 13485 and MDSAP audit readiness.
• Labelling: labels for the domestic market follow NOM-137-SSA1 and must be in Spanish, usually including the registration number, lot or serial number and expiry date where relevant.
• Documents: certificates and other foreign documents may need apostille or legalisation and Spanish translation.

Step-by-step

1. Classify the device and determine whether it is eligible for the reliance route.
2. Appoint the MRH.
3. Collect evidence: reference approvals, quality certificates, test reports and clinical data. See biocompatibility and IEC 60601 for common technical evidence.
4. Prepare Spanish documents and labels, with legalised copies where needed.
5. Submit through the MRH and answer any prevention notices within the deadline.
6. Maintain the registration. Registrations have a fixed validity and must be renewed in time, and the MRH handles incident reports and recalls. See post-market surveillance.

Common mistakes

• Assuming an FDA clearance makes registration automatic.
• Starting legalisation and translation late.
• Choosing an MRH only on price, without checking its record with COFEPRIS.
• Letting the registration expire because nobody owns the renewal date.

Frequently asked questions

Do I need a Mexican company?

Yes. A foreign manufacturer must appoint an MRH, which is a Mexican legal entity.

Does an FDA clearance shorten the process?

It can make you eligible for the equivalence route, which has a shorter target review time, but you still need to meet COFEPRIS’s conditions and submit the local documents.

How long is a registration valid?

Registrations have been granted for five years, and recent reforms are reported to allow longer renewal periods. Confirm the current rule with your MRH.

COFEPRIS rules, routes and review times have changed recently and continue to evolve, and many sources are in Spanish. Confirm the current position with COFEPRIS, your MRH and your regulatory advisers before you act on this guide.

Related reading

• Global market access beyond the US and EU: sequence Mexico with other markets.
• Brazil ANVISA registration: the other large Latin American market.
• US FDA medical device regulations: the main reference approval for Mexico.
• Health Canada medical device licence: another reference route.
• RAC (Devices) study material: covers COFEPRIS and other global systems.

Talk to the AptSkill team

Planning a Mexican registration or building global regulatory skills? Send us your device type, target markets and goal.