COFEPRIS: Speed Up Your Regulatory Process

SANITARY REGISTRATION FOR MEDICAL DEVICES

We ensure your medical device complies with all current COFEPRIS regulations in a fast and efficient way. Our team of experts guides you through every stage of the process — from product classification to obtaining the official registration — guaranteeing the safety, legality, and full compliance of your products in the Mexican market.

Want to Sell Your Medical Devices in Brazil or Colombia?

In addition to obtaining your sanitary registration in Mexico, we also manage all the regulatory procedures required to commercialize your medical devices in Brazil and Colombia. We ensure the legal and successful entry of your products into these markets with the support of our expert LATAM regulatory team.

Why Is It Crucial to Register Your Medical Device with COFEPRIS?

Registering a medical device with the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) is a mandatory requirement for any company that intends to commercialize it in Mexico.

This process not only ensures compliance with legal regulations, but also offers multiple benefits that are essential for patient safety and long-term commercial viability.

COFEPRIS PROCEDURES

Ready to
Take the Next Step?

At Sygo Health, we’re here to guide you through every stage of your COFEPRIS medical device registration. Our team of experts will provide the technical support you need to choose the best submission strategy, ensuring the process is efficient and fast.
Together, we’ll make sure your product is ready for the market in the shortest time possible. Contact us and start your path to success!

Key Steps to Meet
Regulations and Access the Mexican Market

To register a medical device with COFEPRIS (Federal Commission for the Protection Against Sanitary Risks) in Mexico, the process involves several key stages, each of which is critical to ensuring regulatory compliance and a successful registration.

Below, we outline the process, the requirements, and the specifics of having a holder or registration owner in Mexico — a particularly important aspect for foreign brands.

Medical Device
Classification

Class I: Low-risk devices.
Class II: Moderate-risk devices.
Class III: High-risk devices.

The classification is essential, as it determines the specific registration requirements and the amount of time the process may take.

Requirements for Medical Device Registration with COFEPRIS

Once the device classification has been determined, the following documents must be gathered and certain procedures must be completed:

Registration
Holder in Mexico

Foreign brands must designate a registration holder in Mexico—also known as the holder—in order to commercialize their products in the country.
This holder has several responsibilities and specific characteristics that must be considered.

Renewals and Changes
to the Sanitary Registration

In Mexico, a sanitary registration is valid for 5 years, and its renewal or extension is essential to maintain the product’s commercialization.
It is indispensable to submit the renewal request to COFEPRIS before the expiration date, accompanied by the required documentation.

In cases involving changes—such as modifying the distributor—it is necessary to update the registration data to ensure regulatory compliance. These actions guarantee commercial continuity and help avoid legal sanctions. Rely on experts to ensure a fast and effective management of your sanitary procedures. Below, you will find the documentation required for each type of process related to modifications and renewals:

COFEPRIS: Procedures and Services

Regulatory
Procedures and Services

We are a Mexican company committed to providing flexible solutions for the supply of medical inputs in both the public and private sectors.
We work closely with our business partners to expand access to new technologies through sanitary regulation, thereby improving the quality of healthcare in Mexico.
 

At SygoHealth, we are dedicated to offering you high-quality service, ensuring that all your COFEPRIS procedures are carried out efficiently and without setbacks.
Contact us today for more information.

Other COFEPRIS Procedures
COFEPRIS Procedures and Services

At SygoHealth, we specialize in managing and streamlining COFEPRIS procedures, ensuring that your business complies with all required sanitary regulations.
Explore our services and discover how we can help you obtain the authorizations you need.

Cosmetic Regulation in Mexico

At SygoHealth, we handle the entire sanitary regulation process to ensure the safety and effectiveness of personal care and beauty products in Mexico, both domestic and imported.

Registration and Authorization of Dietary Supplements

The dietary supplement market is booming, and at SygoHealth we help ensure that your products meet the highest quality and safety standards.

Obtaining Operating Notices

The COFEPRIS Operating Notice is essential for informing the Health Authority about your establishment and its activities.

Frequently Asked Questions

COFEPRIS Procedures
and Services

Contact
Our Expert Team

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