How to register medical devices and IVDs in Mexico

On September 1, 2025, COFEPRIS’s new Abbreviated Pathway for medical devices and IVDs went into effect and became the primary regulatory route to Mexico. This new pathway makes registration more accessible and efficient for devices and IVDs with prior authorizations in most major device markets. If you were hesitant about pursing COFEPRIS registration before, thinking it would be too expensive, time consuming, or labor intensive, you can now leverage your existing approvals for significantly less submission preparation time.  

In this article, we will cover everything you need to know about how to register medical devices and IVDs in Mexico, including how to qualify for the Abbreviated Pathway, submission requirements, review timelines, and more.

Mexico medical device and IVD regulatory overview

Medical devices and IVDs distributed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risks (COFEPRIS). COFEPRIS develops regulations, Normas Oficiales Mexicanas (NOMs), guidelines, and public announcements in the Federal Register, which is similar to the Official Journal of the European Union. The Regulation of Health Supplies is the regulation that covers regulatory requirements for medical devices and IVDs.  

NOMs dictate specific quality and safety requirements for medical devices and IVDs. Three of the most relevant NOMs are:

• NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices

• NOM-137-SSA1-2025, Medical Device Labeling

• NOM-240-SSA1-2012, Installation and Operation of Technovigilance

Most medical devices and IVDs require pre-market authorization (also called sanitary registration) from COFEPRIS before supplying devices in Mexico. This requires submitting documentation about your device to COFEPRIS for review. On approval, COFEPRIS issues a sanitary registration number, which must appear on your device labeling.

COFEPRIS regulatory pathways for medical devices and IVDs

COFPERIS has two main regulatory pathways: standard pathway and abbreviated (equivalency) pathway:

Standard Pathway requires full technical review of your technical documentation, labeling, safety, and clinical information by COFEPRIS. Review timelines can vary widely based on your device classification and complexity of the review, not to mention the volume of submissions COFEPRIS is managing at the time of submission.

Abbreviated Pathway is an equivalency review pathway in which COFEPRIS grants expedited authorization based on prior approval from a recognized reference authority. Reference authorities accepted for abbreviated review include approvals from IMDRF and MDSAP member markets may be leveraged, including FDA, EU CE marking (MDD, IVDD, MDR, IVDR), Health Canada, Swissmedic, ANVISA, TGA, MFDS, NMPA, and other ICH-, WHO-, IMDRF-, or MDSAP-recognized bodies.

Approval in an accepted reference market does not guarantee eligibility for the abbreviated pathway. The device submitted to COFEPRIS must be identical to the device approved in the reference market in terms of intended use and performance. The reference approval must be no more than five years old, and the device must have a clean safety history (no recalls or safety alerts). Any changes to manufacturer names or sites may also rule out the abbreviated pathway option.  

Key steps in the COFEPRIS medical device registration process

Some of the steps required for the Mexico medical device registration process include:

1. Determine if your product is a medical device and requires registration. All medical devices (including Software as a Medical Device (SAMD)) and IVDs must obtain sanity registration from COFEPRIS before placing the device(s) on the Mexico market. Some very low risk devices are exempt from sanitary registration but must still comply with Good Manufacturing Practice (GMP) requirements and technovigilance. If you have a low-risk device, make sure to check COFEPRIS’s list of low-risk and deregulated devices to confirm its requirements.

2. Classify your device. Confirm the correct classification of your device or IVD as this will determine the submission requirements for your product. Mexico’s medical device classification rules are found in Annex II of the Supplement of Medical Devices of the Mexican Pharmacopoeia.

3. Appoint a Mexico Registration Holder (MRH). Foreign manufacturers must appoint a Registration Holder based in Mexico to submit your registration dossier and liaise with COFEPRIS. Your Sanitary Registration will be issued in the name of your MRH and they will effectively own the registration.

4. Obtain a compliant Warehouse Notice. Before applying for COFEPRIS registration, you must have proof that the warehouse where your devices will be stored in Mexico holds the required Establishment License and employs a Quality Manager. This documentation is required for your submission.  

5. Compile and submit your documentation to COFEPRIS. Your MRH submits all necessary information and documentation required for your device. COFEPRIS reviewers can request more information about your product, called a prevención, which pauses the review clock for your application. You usually have 30-60 days to provide the requested information.

6. Decision. If approved, you will receive an applicable registration number. Registrations are valid for five years; renewals may be valid for up to 10 years.

You must comply with COFEPRIS’s rigorous post-market surveillance and vigilance requirements to maintain the validity of your registrations. However, this article will focus on pre-market registration requirements.

Medical device and IVD classification in Mexico

Medical device classification rules are published in the Mexican Pharmacopeia (Farmacopea de los Estados Unidos Mexicanos or FEUM) and are based on the International Medical Device Regulators Forum (IMDRF) and Medical Devices Directive MDD 93/42/EEC. New rules added in 2023 brought the classification scheme in closer alignment with the EU Medical Device Regulation (EU MDR).  

COFEPRIS medical device classification tiers

There are three main classification tiers with an additional category for very low risk devices:

• Class I (Low Risk): Devices that present little risk to patients and users (e.g., bandages and tongue depressors).

• Class I: Non-active, minimally invasive devices that do not directly affect vital functions but may present some risk to patients (e.g., certain surgical scalpels and contact lenses).

• Class II: Devices with moderate risk can include invasive devices (e.g., diagnostic imaging devices and inhalers).

• Class III: Devices that pose significant risks to patients and directly affect vital systems or mucus membranes, or are implantable (e.g., life supporting devices and cardiac pacemakers).

Low-risk devices require sanitary registration, but COFEPRIS review time is expedited relative to other classes. As stated, some listed low-risk devices can be marketed without sanitary registration if you maintain an appropriate QMS and meet all post-market monitoring and technovigilance requirements.  

COFEPRIS IVD classification tiers

The Pharmacopoeia includes separate rules specific to IVDs. IVDs are classified into three risk tiers according to individual and public health risk:

• Class I (Low Risk): Products with low to negligible risk for both the individual and public health (e.g., general laboratory equipment and basic sample collection tools).

• Class II (Moderate Risk): Devices with moderate individual risk and low public health risk (e.g., blood glucose meters).

• Class III (High Risk): Products that pose a high individual risk or a significant public health risk (e.g., assays for detecting HIV, Hepatitis B/C, blood grouping systems, and companion diagnostics).

COFEPRIS Medical Device and IVD Pre-Registration Requirements

Obtain a Mexico Registration Holder and in-country support

All foreign manufacturers need an MRH to sell medical devices and IVDs in Mexico. This relationship must be established through a formal agreement, and you must include a Letter of Representation with your submission. The MRH is a person or entity located in Mexico who legally represents your company to COFEPRIS during the sanitary registration process. The MRH is responsible for submitting the registration dossier to COFEPRIS, managing the approved registration, and adding or removing distributors from the sanitary registration. Your MRH partner should be very knowledgeable about COFEPRIS requirements and verify that your submission complies with their expectations.

The MRH is named on the device labeling as the legal sanitary registration owner, making them accountable for ensuring compliance with post-market requirements on behalf of the foreign manufacturer. For this reason, it is best to separate the MRH and distributor roles. This separation allows you to freely manage distributors, proactively maintain post-market compliance obligations, and renew registrations without conflicts of interest.  

In addition to your MRH, you will also need an importer of record, a distributor with a compliant warehouse, and a customs broker to bring your devices into Mexico. These agents facilitate compliance with labeling, storage, post-market surveillance, and customs requirements in collaboration with your MRH. Technical agreements that outline the roles and responsibilities of each party are required.

Obtain proof of GMP Compliance

COFEPRIS requires proof that your company and manufacturing facilities comply with Good Manufacturing Practice (GMP) requirements. Several forms of quality management system (QMS) evidence are accepted, including:

• MDSAP Audit Certificate  

• ISO 13485:2016 Certification

• CE Mark Certificate  

• Free Sale Certificates that include GMP compliance

All documents must be original or certified copies provided in Spanish or English with a certified translation if the original document is in another language. Physical documents must be apostilled or legalized in the country of origin (electronic documents are authenticated via the issuing agency’s website).  

Required Documentation for COFEPRIS Registration

Exact documentation requirements vary by device class. Lower risk devices require minimal documentation while higher risk devices can require extensive clinical evidence, including clinical trials, and risk management files to ISO 14971. However, the following documents are needed for most applications.

Core documents required for all applications:

• COFEPRIS registration form: The primary application form that captures the device’s intended use, technical characteristics, and manufacturing information.

• Foreign approval (as applicable) and Technical File: A structured dossier of design specifications, materials, and clinical, safety, and performance data assembled to demonstrate that the device meets Mexican safety and efficacy standards.

• GMP evidence: COFEPRIS accepts several forms of QMS evidence, including ISO 13485:2016 certification, and MDSAP Audit Certificate. In addition, as part of the foreign approval, documents such as a CE Mark Certificate and a Free Sale Certificate are required.

• Spanish Labeling Samples: All labeling materials, Instructions for Use (IFU), and promotional content must be translated into Spanish and formatted to meet NOM-137-SSA1-2025.

Mexico COFEPRIS Processing Times

COFEPRIS review timelines vary by device classification and registration pathway. The agency has historically struggled with backlogs and long review times but has taken steps to address this with harmonization and is now publishing aggressively shorter review timelines:

Approximate COFEPRIS Review Timelines for Standard Pathway:

• Class I: 20–30 days

• Class II: 30–60 days

• Class III: 60–180 days

Approximate COFEPRIS Review Timeline for Abbreviated Pathway:

• All classes: 30 business days

The above timelines are only targets. Actual timelines can vary based on submission quality, classification, and complexity, as well as COFEPRIS’s submission volume.  

Realistic review times for COFEPRIS submissions are:

• 12-15 for the Standard Pathway and

• 3-6 months for the Abbreviated Pathway.

Faster COFEPRIS Registration is here

For manufacturers already holding approval from a recognized international regulatory authority, Mexico's Abbreviated Pathway offers a significantly faster route to market. That said, Abbreviated registration is not a simple copy and paste process. Gaps in documentation can still create delays. And you need to appoint an experienced MRH for representative and on-the-ground regulatory support in Mexico. Pure Global's team in Mexico has deep expertise in COFEPRIS medical device registration and can act as your MRH, all for a flat annual fee.  

Contact us to talk to an expert.

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