Mexico COFEPRIS Medical Device Regulations

Our regulatory consulting specialists support regulatory compliance with the COFEPRIS requirements.

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Mexico COFEPRIS Medical Device Regulations

COFEPRIS AUTHORITY

COFEPRIS Medical Device Regulations

Navigating medical device registration in Mexico can be complex, but Qserve is here to make it simple and efficient. We guide you through the regulatory process, helping you comply with the standards set by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), part of Mexico’s Ministry of Health.

COFEPRIS oversees the approval and regulation of medical devices under two main laws:

The General Health Law (Ley General de Salud)
The Regulations of Health Supplies (Reglamento de Insumos para la Salud)

Our team ensures that your submissions meet all COFEPRIS requirements so your devices can be registered and marketed without unnecessary delays. With expertise across the entire process, we simplify compliance, providing a seamless path to success in the Mexican market.

GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT

Do you need assistance with your strategy for the Mexican COFEPRIS Medical Device Regulations?

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Medical Device Classification in Mexico

Risk-based classification

Device Risk Classification	Risk Description	Description
Class I low	Low	NA
Class I	Low-Medium	Those medical devices are proven to be safe and generally not introduced into the body.
Class II	Medium	Devices known in medical practice may have variations in the material with which they are made and, generally, are introduced into the body for less than thirty days.
Class III	High	New or recently accepted medical devices or those introduced into the body remain in it for more than thirty days.

The criteria for registering medical devices in Mexico focus on key factors such as use, activity, contact, and permanence with the body. These criteria serve as clear rules that manufacturers must follow to ensure compliance with regulatory standards.

Mexico’s system draws from international frameworks, including:

The Global Harmonization Task Force (GHTF), now known as the International Medical Device Regulators Forum (IMDRF).
The EU Medical Devices Directive (MDD) 93/42/EEC.

The revised rules also align with updates from the EU Medical Devices Regulation (MDR) 2017/745. By understanding and applying these rules, you streamline the process of obtaining registration for your medical devices in Mexico.

Medical Device Approval Mexico

Regulatory Approval Process

Getting your medical device approved in Mexico involves a clear step-by-step process. Here's how we at Qserve can help you navigate it smoothly:

Ensure your medical device is classified correctly based on its intended use and risk level. Proper classification is the foundation of a successful submission.
Designate a trusted MRH to coordinate the regulatory process. The MRH is responsible for submitting the required documents to COFEPRIS.
Submit a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) to demonstrate that your device is approved in its home country.
Your device must meet ISO 13485 standards or an equivalent certification. Mexico does not require an additional audit if your device complies with international standards.
Once COFEPRIS approves your device, they will issue a certificate and confirm the registration on the Ministry of Health website.
Create a comprehensive dossier that includes:

Safety information
Testing reports
Clinical trial data

If your device is already approved in recognized countries like Japan, Canada, or the United States, you can use that approval to streamline the process.

Go-to-market strategy

Mexico is a medical device market with explosive growth, and the possibilities are almost endless for device manufacturers, especially for those who have already obtained registration in Japan, the USA, and Canada.

COFEPRIS slowly aligns the regulation to EU regulation which opens opportunities for CE-marked devices to enter the market faster.

Free introductory call

Mexico vs EU/US Medical Device Regulations

Appoint of Mexico Registration Holder
Labelling must be in Spanish
Import permits required for Class III implantable devices
All documents included in the registration dossier shall be translated into Spanish
Although, translation to Spanish is no longer mandatory for technical documents that are provided in English (e.g., for class III implantable devices).

Qserve services for Mexico

Global Regulatory Strategy
Registration support in Mexico
Cofepris certification
Review process technical documentation
QMS ISO 13485 support
Translation label and IFUs based on requirements
Conformity Assessment route support

Services

Representation for foreign manufacturers

Mexican Registration Holder (MRH)

Foreign manufacturers require a local Authorised Representative, also known as a Mexico Registration Holder (MRH), to interact on their behalf with COFEPRIS and own the registration. The Mexican Registration Holder (MRH) must also be a Mexican legal entity.

Main responsibilities of the holder:

To be the main point of contact in Mexico with COFEPRIS.
Apply for any process with COFEPRIS related to the registrations or any product.
Report any incidence in terms of Technovigilance

Benefits of having a holder as a commercial partner:

Assign or remove local distributors, avoiding dependence on them.
Have a localally, with a local presence to oversee your sanitary authorizations.

Equivalency agreement (class II and III)

The equivalence route is applicable for products approved by US FDA, Health Canada (only for Class II-IV) and Japan (only for Class II-IV). For these types of devices, there is an expedited review process, allowing for faster review and approval.

Time: 8-11 months for FDA and HC approved products and 5-8 months for Japan (Equivalence Agreement of 2012).
The option for Third Party Reviewers is not applicable for this route.
COFEPRIS fee: $500-1,100 USD depending the device class.

If your product only has European CE Marking or other national approval, it is possible to leverage information from your existing Technical File or registration dossier to prepare your submission to COFEPRIS.

Contact us to see to what extent your existing documentation can be suitable for achieving regulatory compliance in Mexico

Standard (class I)/Standard+Third-Party Review process

Time:
Generally, 12 months or, in the case of a third-party reviewer, around 3 to 6 months upon submission.

Third-Party Reviewer:
$2,000-4,000 USD , depending on the reviewer and the device class.

COFEPRIS fee: $500-1,100USD depending on the device class.

Important links and guidance

General Health Law (Overarching regulatory framework for medical devices (and drugs)
Regulation of Health Supplies (Regulation outlining medical device requirements in Mexico. The latest amendment was issued on May 31, 2021)
NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices (Provides the minimum requirements for the design, development, manufacture, storage, and distribution of medical devices in Mexico.)

How can we help you? Contact us

Mexico COFEPRIS Medical Device Regulations

COFEPRIS Medical Device Regulations

Do you need assistance with your strategy for the Mexican COFEPRIS Medical Device Regulations?

Risk-based classification

Regulatory Approval Process

Mexican Registration Holder (MRH)

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