Medical Devices

We advice you on a fast and effective way to access the market. Submissions to COFEPRIS.

We advice you on a fast and effective way to access the market. Submissions to COFEPRIS.

At IPS, our regulatory affairs services for medical devices are tailored to meet the unique needs of our clients in the industry. Our team of experienced professionals is well-versed in the intricate regulatory landscape surrounding medical devices. Our services include conducting thorough regulatory assessments, preparing and submitting regulatory applications, and ensuring compliance with all applicable laws and regulations. We strive to navigate the complex regulatory requirements efficiently and effectively, helping our clients bring their medical devices to market in a timely manner while maintaining the highest standards of safety and quality.

    • Regulatory Pathway Assessments

    • Inquiries to COFEPRIS

    • Registration of all classes and categories

    • In-country representation (hosting)

    • Administrative and technical modifications

    • Renewals

    • Operating License

Medical Devices must be registered with the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) before they can be imported, distributed, or sold in Mexico. In specific cases, such as products imported for immediate personal use or clinical research, certain exemptions may apply.

In Mexico, you can submit for COFEPRIS approval via two primary routes: the Standard Review Process (Vía Ordinaria) or the newly consolidated Abbreviated Regulatory Pathway (Reliance).

We provide end-to-end support across both active registration pathways. The pathway determines your overall project costs, documentation requirements, and approval timelines.

  • The Standard Review Process (Vía Ordinaria) This is the traditional and most common route to market, where your registration dossier is submitted directly to COFEPRIS for full technical, legal, and scientific evaluation. Because this route involves a comprehensive, line-by-line review of your device’s clinical and manufacturing data, meticulous dossier assembly—aligned strictly with Mexican Standards (NOMs) and the Mexican Pharmacopeia (FEUM)—is vital to prevent delays.

    While statutory review times are short, real-world processing times typically range from 6 to 12 months due to administrative backlogs.

    IPS ensures your technical dossier is compiled flawlessly from day one to navigate this pathway as smoothly and quickly as possible.

  • The Abbreviated Regulatory Pathway (Vía Regulatoria Abreviada) is COFEPRIS’s modernized Reliance-based framework. It allows medical device manufacturers to fast-track Mexican registrations by leveraging prior approvals from recognized Reference Regulatory Authorities (ARR), including members of the International Medical Device Regulators Forum (IMDRF) such as the US FDA, European Notified Bodies, Health Canada, China, Japan's MHLW/PMDA, and Australia's TGA. By relying on these rigorous global evaluations, COFEPRIS bypasses duplicate technical reviews, thereby issuing approvals in a shorter timeframe.

    ⚠︎ Strict Qualification Required: To qualify, the technical dossier submitted to COFEPRIS must exactly match the approved configuration in your reference country. Additionally, your reference approval must be an ordinary, standard authorization (emergency, temporary, or accelerated approvals are not eligible)

⚠︎ COFEPRIS times are constantly changing; therefore, our team will keep you updated with the latest estimated approval times in addition to ways to help expedite the process. Since 2020 there has been a considerable backlog for COFEPRIS to review applications.

Categories & Classes

In Mexico, Medical Devices are divided into seven categories and four classes.

    1. Medical Equipment

    2. Prostheses, Orthoses and Functional Aids

    3. Diagnostic Agents

    4. Supplies for Dental Use

    5. Surgical and Healing Materials

    6. Hygiene Products

    7. Software as a Medical Device

    1. Low Risk

    2. Class I

    3. Class II

    4. Class III

Resources

download

93 Low-Risk Products

2,088 Deregulated Products

(Published 2025)

Authorized representative registration Holder

Foreign medical device manufacturers can commercialize their products in Mexico by appointing IPS as their in-country representative. Learn more here.

Know the Mexican market

Our market intelligence service will allow you to identify the market potential, trends, key actors & competitors. Learn more here.

home