Mexico Deregulates Over 500 Medical Device Types

Medical device companies doing business in Mexico had cause to celebrate recently, with the news that that country's regulator had significantly expanded the number of products that no longer require official registration to be sold within its borders. In total, COFEPRIS has removed 573 medical devices from approval process list, a decision that was based primarily on their status as low-risk products in terms of patient health.

Also factoring in to the COFEPRIS decision were the many medical devices that served as components of other products, or in some cases accessories, which obviated the need for their official approval at the individual level. These including staining solutions, cables, certain types of cartridges, and even software associated with a medical device. In effect, these products are no longer considered 'medical devices' in Mexico.

Like the United States, Mexico offers a three-tier classification system for medical devices based on risk. Unlike FDA approval standards, however, Mexico's' COFEPRIS regulator models itself after EU practices, with a number of changes distinct to the Mexican market.

In addition to COFEPRIS, medical device companies can also work through a third party reviewer identified by the agency to pre-approve certain types of medical device applications. Some devices also benefit from equivalency status if they are already approved for sale with the FDA, in Japan, or with Health Canada, depending on their particular class.

With transparency and time-to-market delays listed as frequent pitfalls of the Mexican medical device approval process, the ability to avoid these regulatory hurdles and begin selling certain types of products immediately is an obvious advantage for medical device companies. Mexico's decision to streamline its approval system by removing restrictions on over 500 product types should lure a greater number of industry players into the market, which is the fourth-largest in North and South America.

0 2008-01-18T13:10:54 Administrator


  • Medical Device