Mexico

COFEPRIS Mexico Medical Device Registration

Medical device manufacturers must obtain regulatory approval from COFEPRIS, Mexico's medical device regulator, before distributing devices in Mexico. Foreign manufacturers must appoint an in-country representative to submit your registration dossier and application fees.

Pure Global simplifies the process with AI workflows that accelerate COFEPRIS submission preparation, along with local support and representation, all for a flat annual fee.

Pricing

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$12.6bn

MD Market size

7.6%

MD Market CAGR

$2.2b

IVD Market size

5.50%

IVD Market CAGR

90%

MD Imports

11%

Aging Population

Mexico’s medical devices market is set to grow at a 7.6% CAGR (2024–2029), despite short-term economic challenges. Growth is driven by higher healthcare spending, an aging population, and rising chronic diseases. The in-vitro diagnostics market is expected to reach $3.5B by 2033.

Axel Juarez

Senior Regulatory Affairs Consultant, Mexico

Device Classification and Regulatory Pathways

How to register a medical device in Mexico

Medical device and In Vitro Diagnostic (IVD) device registrations in Mexico are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). Registration requirements are established under the General Health Law (Ley General de Salud) and the Regulations of Health Supplies (Reglamento de Insumos para la Salud), alongside applicable NOM standards such as NOM-241-SSA1-2025 for Good Manufacturing Practices.

Foreign manufacturers must appoint a local Mexico Registration Holder (MRH). The MRH is a legally established entity in Mexico who acts as the official representative for the foreign manufacturer. The MRH is responsible for obtaining and holding the sanitary registrations for your medical devices, as well as coordinating with COFEPRIS. It is possible to transfer your registrations to a different holder through formal regulatory channels. However, this process can be cumbersome, so it’s important to thoroughly vet your chosen MRH. Once appointed, the MRH will identify which regulatory pathways, depending on the product and available reference approvals, the foreign Manufacturer shall follow.

COFEPRIS Mexico medical device regulatory pathways

Mexico offers two registration routes: the Standard Route and the Equivalency (Abbreviated) Route:

Standard Route (Full Technical Review)

Process: COFEPRIS conducts a comprehensive review of the submitted technical dossier, including clinical, safety, and labeling documentation.

Requirements: A complete technical file with clinical and safety data, quality system evidence, labeling in Spanish, a Free Sale Certificate or Foreign Government Certificate, and a Letter of Representation.

Timeline: Review timelines vary due to the complexity and volume of submissions.

Renewal: Initial registrations are valid for 5 years; subsequent renewals may be granted for up to 10 years.

Equivalency Route (Abbreviated Pathway)

Process: COFEPRIS grants expedited authorization based on prior approval from a recognized reference authority.

Eligibility: Effective September 1, 2025, 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.

Requirements: The device must be identical to the version approved by the reference authority. Required documentation includes a Certificate of Free Sale and conformity assessment, foreign approval, Clinical Evaluation Report, risk analysis, draft labeling in Spanish, and quality system evidence.

Timeline: COFEPRIS should issue a decision within 30 business days of receiving a complete application. Delays may occur when there is a high volume of submissions.

Renewal: Initial registrations are valid for 5 years; subsequent renewals may be granted for up to 10 years.

Other COFEPRIS registration requirements

Mexico Registration Holder (MRH): Mandatory for all foreign manufacturers. The MRH submits applications, pays fees, and acts as the local regulatory contact with COFEPRIS.

Distributor information: Distributor details must be confirmed and included in the application materials.

Translation: All submissions and labeling must be in Spanish.

Quality system evidence: While ISO 13485 is not legally required, COFEPRIS expects evidence of a robust quality management system, such as ISO 13485 certification, CE Mark, MDSAP, or a Certificate of Good Manufacturing Practices.

Post-market obligations: Manufacturers must maintain post-market surveillance systems, including adverse event reporting, throughout the registration lifecycle.

What documentation is required to register a medical device or IVD with COFEPRIS?

Documentation requirements depend on the device classification and registration route, but a complete dossier generally includes:

Free Sale Certificate or Foreign Government Certificate (from reference market if using Equivalency route)

Certificate of Good Manufacturing Practices, ISO 13485, CE Mark, MDSAP, etc.

Foreign approval (required for Equivalency route)‍

Technical file, including clinical and safety data (required for Standard route) ‍

Device labeling in Spanish

Letter of Representation

Technovigilance Report

What is a Mexico Registration Holder and why do you need one?

Before submitting a medical device or IVD registration to COFEPRIS, foreign manufacturers must appoint a Mexico Registration Holder (MRH) to serve as their local regulatory representative. The MRH is responsible for submitting registration dossiers, paying government fees, and maintaining communication with COFEPRIS throughout the product’s approval and post-market lifecycle.

Sanitary registrations in Mexico are issued in the name of the MRH. This means the MRH is legally recognized as the registration holder. Because transferring a registration to a new MRH typically requires a formal process with COFEPRIS, manufacturers should evaluate potential representatives carefully before proceeding.

Do foreign medical device manufacturers also need an importer and a distributor in Mexico?

Yes. Foreign manufacturers typically need an MRH, an authorized importer, and distributor to distribute medical devices and IVDs in Mexico. The MRH acts as the legal regulatory representative and holds the sanitary registration issued by COFEPRIS, while the importer and distributor are responsible for physically bringing the product into Mexico and ensuring compliance with customs and labeling requirements. These roles can be fulfilled by the same organization or by separate entities, but all must be documented and authorized as part of the regulatory process.

more information on MExico

Medical Device Regulations

Classification and Grouping

Medical Device Labeling

Postmarket Compliance

Documents and links

COFEPRIS

General Health Law

Regulation of Health Supplies

NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices

COFEPRIS Mexico Medical Device Registration Pathway

How We Can Help

Faster submissions. Predictable costs. Local support.

We provide turnkey regulatory support in Mexico, all for a flat annual fee:

Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.

In-country representation, with Pure Global serving as your Mexico Registration Holder.

Post-market surveillance support, including vigilance reporting and authority communications.

Importer authorizations, post-approval modifications, and renewals.

Frequently
Asked Questions

What is the cost to register a medical device in Mexico?

The cost of COFEPRIS registration depends on the device classification, dossier complexity, and whether multiple registrations are filed together:

Low Risk (LR) devices: Registration costs generally range from $1,000 to $2,000, including government fees and translation costs.
Class I devices: Costs are typically $3,000 to $4,000 per registration.
Class II/III devices: Higher-risk devices usually cost between $5,000 and $7,000 per registration. Submitting multiple devices together can reduce the average cost per registration.
All COFEPRIS registrations are valid for 5 years. Renewal costs are capped at no more than 50% of the original registration fee.

Ongoing expenses include an annual fee to the local representative, fees for processing modifications, and costs for post-market surveillance (PMS) and vigilance activities. A budget of about $5,000 per year should cover these obligations, but costs can increase if extensive vigilance is required or a large number of modifications are filed.

Use our Fee Calculator to estimate your market entry costs in Mexico.

What government fees apply to medical device registration and renewal in Mexico?

COFEPRIS charges mandatory government fees based on medical device risk class and whether the application is for new registration or renewal. All fees are assessed per product.

For new medical device registrations, COFEPRIS charges the following one-time fees:

Class I and Class I Low Risk: MXN 16,499 (approximately USD 933) per product

Class II: MXN 24,198 (approximately USD 1,369) per product

Class III: MXN 30,798 (approximately USD 1,742) per product

For registration renewals, which are required every five to ten years, the applicable fees are:

Class I and Class I Low Risk: MXN 12,374 (approximately USD 700) per product

Class II: MXN 18,149 (approximately USD 1,027) per product

Class III: MXN 23,098 (approximately USD 1,307) per product

All fees listed are government fees only and do not include consulting services, dossier preparation, translations, or in-country regulatory representation. Additional fees can apply, and fees can change without notice.

Check our Fee Calculator for up-to-date government fees in 14 markets.

How long does it take to register a medical device in Mexico?

Timelines for COFEPRIS registration vary by pathway, device class, and dossier completeness. Compiling and submitting an application typically takes 3–4 weeks once all requirements are met.

The new Abbreviated Pathway (Equivalence Route), which leverages prior approvals from many international regulators, introduced a target COFEPRIS review time of 30 working days. While the target review time represents a major improvement from prior COFEPRIS review times, some submissions may still take longer than 30 days for approval.

Does Mexico require ISO 13485 certification to register a medical device?

While ISO 13485 is not legally mandatory, COFEPRIS expects manufacturers to provide evidence of a robust quality management system. Acceptable documentation includes an ISO 13485 certificate, CE Mark, MDSAP, or a Certificate of Good Manufacturing Practices. These support your application, especially for the Equivalence route, and help demonstrate compliance with safety and performance standards.

Are there specific medical devices that do not require health registration in Mexico?

Yes, there is a specific list of medical devices classified as low risk, which determines whether health registration is mandatory or not. Devices on this list may not require registration, simplifying the process for certain low-risk products in the Mexico medical device market.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.