Medical Device and IVD Registration in Mexico

Mexico is the second largest medical device market in Latin America (Brazil is first) and can be a profitable target for medical device manufacturers, especially those located in the US and Canada. However, Mexican registration requirements are confusing and little information on the process is available in English from COFEPRIS, a division within the Mexican Ministry of Health (Secretaria de Salud) responsible for medical device and IVD oversight. Emergo Mexico, our medical device consulting division based in Mexico City, can help obtain approval for your medical device or IVD in Mexico. We can:

• Determine classification of your medical device in Mexico
• Gather, prepare and submit registration documents to COFEPRIS
• Work to answer questions from COFEPRIS during the submission process
• Act as your independent "Mexico Registration Holder"  
• File necessary paperwork to obtain a Import Permit (only required for implantable devices) 

The Mexican medical device approval process

Medical devices in Mexico are divided into three classes of increasing risk: Class 1, Class 2 and Class 3. The registration process can be challenging in Mexico because there is no published list that allows manufacturers to ascertain the classification of their device before beginning the registration process with COFEPRIS. However, our consulting team in Mexico has access to an unpublished import Customs database of medical devices that allows us to determine if the product is a medical device/IVD and its proper classification before beginning the registration process. Ultimately, COFEPRIS decides the classification of a particular medical device or IVD upon submission of the registration documents but we typically do not encounter differences between the classification determined by our experts and the COFEPRIS decision.

Read our informative article about the medical device registration process in Mexico.

COFEPRIS registration services

Emergo Mexico will provide a detailed list of all the documentation that is required when registering your medical device or IVD in Mexico. Here are a few of the documents that will be required:

• Certificate of Free Sale from the Ministry of Health in the country of origin
• Current ISO 13485 certificate, CE Marking certificate or Declaration of Compliance with US GMP included in the Certificate of Free Sale
• Technical and scientific data that demonstrates safety and efficacy of the device
• Detailed information on medical device structure and operation
• List of accessories, if applicable
• Proposed labeling and instruction manual in Spanish
• Overview of the sterilization and/or manufacturing process
• Lab tests, if applicable
• Clinical data, if applicable

Preparation of the Mexico medical device registration documents takes up to 2 months and a decision from COFEPRIS is typically rendered 4-12 months thereafter. COFEPRIS charges registration fees per product (depends on classification) and registration is valid for 5 years. In addition, an Import Permit is required for implantable medical devices and Emergo Mexico can help you obtain this permit after the registration process.

Please contact us for more information or a free proposal on medical device registration and approval in Mexico.