Mexico's COFEPRIS Exempts Hundreds of Devices from Registration Requirements

Regulatory News

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

Mexican regulators have expanded their list of healthcare products that do not require registration and approval to be sold in the country.

COFEPRIS, Mexico’s medical device market regulator, added 573 items to its list of products (link in Spanish) not considered medical devices, effectively removing registration as a requirement for importation, distribution or sale of these products in Mexico. Most of the products added to the no-registration list share low-risk profiles, or are components or accessories to other medical devices.

Products most recently added to Mexico’s no-registration list include patient positioning equipment, artificial teeth and staining solutions, as well as automatic and manual patient beds, hardware and cables for monitors and reagent cartridges. Most notably, standalone software remains on the list of products not required to register with COFEPRIS.

The breadth of medical products added to the COFEPRIS list will impact a wide swath of manufacturers now able to commercialize their goods in Mexico with significantly less market authorization requirements.

For more information, see our video overview of the Mexican medical device registration process.

Read the Original Blog Post at Emergo

Related: Mexico Updates Lists of Class Ia Devices, Third-Party Reviewers

Related: COFEPRIS Device Seizures Demonstrate Importance of Proper Medical Device Labeling in Mexico