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COFEPRIS Medical Device Regulations

Expert guidance for COFEPRIS compliance in Mexico. We support registration, documentation, and local representation for smooth market access.

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:

  1. The General Health Law (Ley General de Salud)
  2. 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.

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Services

Qserve services for Mexico

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Global Regulatory Strategy

We develop tailored regulatory strategies to support your global market goals, ensuring your product meets requirements in Mexico and beyond.

Registration Support in Mexico

Our team guides you through every step of the COFEPRIS registration process, from dossier preparation to final approval.

COFEPRIS Certification

We assist in obtaining the necessary certification from COFEPRIS for your medical devices and IVDs, enabling legal market access in Mexico

Review of Technical Documentation

We perform a thorough review of your technical file to ensure it meets COFEPRIS standards and is ready for submission.

QMS ISO 13485 Support

Our experts support you in aligning your Quality Management System with ISO 13485 and Mexican regulatory expectations.

Translation of Labels and IFUs

We provide accurate translations of product labels and Instructions for Use (IFUs) in compliance with COFEPRIS language and formatting requirements.

Conformity Assessment Route Support

We help identify and follow the appropriate conformity assessment route for your product, ensuring regulatory compliance and efficient approval.

Risk Classification Assessment

We support you in determining the correct risk class for your medical device under COFEPRIS, which is essential for defining your regulatory pathway.

Gap Analysis

Our team reviews your documentation and systems to identify gaps against COFEPRIS regulatory requirements, helping you prepare a complete submission.

Risk Management Support

We help you develop or align your risk management files in accordance with ISO 14971 and local COFEPRIS expectations.

Clinical Evaluation & Studies

Qserve assists in collecting and presenting relevant clinical data, including literature reviews or local study coordination, when required for registration.

Post-Market Surveillance (PMS)

We support your PMS planning and activities, including complaint handling and vigilance, in line with COFEPRIS post-market expectations.

Representation for foreign manufacturers

Medical Device Approval Mexico

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:

  1. Ensure your medical device is classified correctly based on its intended use and risk level. Proper classification is the foundation of a successful submission.
  2. Designate a trusted MRH to coordinate the regulatory process. The MRH is responsible for submitting the required documents to COFEPRIS.
  3. Submit a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) to demonstrate that your device is approved in its home country.
  4. 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.
  5. Once COFEPRIS approves your device, they will issue a certificate and confirm the registration on the Ministry of Health website.
  6. 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.

Get in touch for more information about Mexico Market Access
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Mexican Registration Holder (MRH)

Foreign manufacturers that wish to market medical devices in Mexico are required to appoint a local Authorized Representative, also known as a Mexico Registration Holder (MRH). This representative must be a legal entity based in Mexico and is responsible for acting on behalf of the manufacturer in all regulatory interactions with COFEPRIS, the Mexican health authority. The MRH serves as the official point of contact in Mexico and is responsible for managing all processes related to product registration and maintenance. This includes submitting applications, handling updates, and reporting incidents through Technovigilance in accordance with regulatory requirements. Choosing a commercial partner as your Registration Holder offers strategic advantages. It allows you to assign or replace local distributors without being dependent on a single party. Moreover, it ensures you have a reliable local presence to manage and protect your sanitary authorizations effectively.

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

Medical Device Classification in Mexico

Risk-based classification

Screenshot_23-7-2025_172714_www.qservegroup.com

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.

Market Access
Differences Between Mexico and EU/US Regulations
Appointment of Mexico Registration Holder

Manufacturers must appoint a local Registration Holder in Mexico to manage interactions with COFEPRIS and handle importation and distribution.

Spanish Labelling Requirements

All medical device labels must be fully translated into Spanish to comply with COFEPRIS regulations.

Import Permits for Class III Devices

Import permits are required for high-risk, implantable Class III devices before market entry.

Spanish Translation of Documentation

All documents in the registration dossier must be translated into Spanish.<br>Note: For Class III implantable devices, English-language technical documents may be accepted.

Standard vs Third-Party Review Process

COFEPRIS offers two pathways: the standard review and an accelerated third-party review process for faster market access.

Estimated Timelines

standard review: 12 months after submission and third party review: 3–6 months depending on reviewer efficiency

Third-Party Reviewer Fees

Costs range from $2,000–$4,000 USD, depending on the reviewer and the classification of the medical device.

COFEPRIS Government Fees

Expect a fee between $500–$1,100 USD, based on your product's device class.

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.

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