COFEPRIS Mexico Medical Device Registration
As the second-largest country in Latin America, with a population exceeding 125 million and major urban centers in Mexico City, Monterrey, and Guadalajara, Mexico represents a significant market for medical devices, with approximately 80% of devices imported. This import reliance highlights the substantial opportunities for foreign medical device manufacturers seeking Mexico medical device registration.
Navigating COFEPRIS Regulations
Regulatory Authority
Mexico's medical device regulator is the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Pure Global can assist with Mexico's medical device registration and act as your Mexico Registration Holder (MRH), ensuring COFEPRIS approval to sell in the Mexican market.
Classification
A product is considered a medical device in Mexico if it falls into one of six categories based on its function and purpose, which are: medical equipment, prosthetics, orthotics and functional aids, IVDs, dental supplies, surgical and dressing materials, hygiene and SAMD. After identifying the category, medical devices are classified based on their permanence or degree of exposure to the human body and will be classified for registration purposes according to the risk involved in their use in class I, II or III. There are medical devices that by nature are classified as low risk. For these products, there is a specific list that will determine whether health registration is mandatory or not.
Key Requirements
To market in Mexico, foreign manufacturers must:
- Appoint a local Holder responsible for the registration process with COFEPRIS.
- Prepare and submit a comprehensive technical dossier, considering the Equivalency Agreement route for expedited review if applicable.
- Ensure registrations are renewed every five years to maintain market presence.
- Certificate of Good Manufacturing Practices or ISO 13485
- Certificate of Free Sale
- Letter of Representation
Tailored Support for Market Entry
Our expertise in Mexican regulations provides seamless market entry:
Guidance on product classification and the most efficient regulatory pathway.
Compilation of the technical dossier required for COFEPRIS registration.
Acting as your Holder, managing the submission process and ensuring compliance with post-market obligations.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in Mexico?
The primary regulatory authority for medical device registration in Mexico is COFEPRIS (Federal Commission for the Protection against Sanitary Risks). Pure Global can assist with navigating the registration process to ensure COFEPRIS approval for selling medical devices in the Mexican market.
How are medical devices classified in Mexico, and what are the categories?
In Mexico, a product is considered a medical device if it falls into one of six categories based on its function and purpose, as defined by Mexico medical device registration: • Medical equipment • Prosthetics, orthotics, and functional aids • In vitro diagnostics (IVDs) • Dental supplies • Surgical and dressing materials • Hygiene and Software as a Medical Device (SAMD) Medical devices are further classified into Class I, II, or III based on their permanence or degree of exposure to the human body and the associated risk involved in their use.
What are the key requirements for foreign manufacturers to market medical devices in Mexico?
Foreign manufacturers must: 1. Appoint a local holder responsible for the COFEPRIS medical device registration process. 2. Prepare and submit a comprehensive technical dossier. 3. Consider the Equivalency Agreement route for expedited review if applicable. 4. Ensure registrations are renewed every five years to maintain market presence. 5. Provide a Certificate of Good Manufacturing Practices or ISO 13485. 6. Provide a Certificate of Free Sale. 7. Provide a Letter of Representation.
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.
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