Mexico Exempts Hundreds Of Medical Devices From Registration

By Chuck Seegert, Ph.D.

Regulators in Mexico have increased the list of medical devices and healthcare products that no longer require registration. This list of items largely consists of components and accessories of other, low-risk devices. Many manufacturers could be impacted by the change.

Mexico is one of the largest medical device markets in Latin America, second only to Brazil. Because of this, it is often considered by manufacturers to be a market with high-profit potential. Medical devices in Mexico are divided into four classes based on their increasing risk, including Class I “low risk,” Class I, Class II, and Class III. These classifications are similar to the European classifications, with some unique differences.

Mexico’s medical device market regulator COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) maintains a list of items that it doesn’t consider medical devices, according to a recent blog post from the Emergo Group. This list has now expanded, as COFEPRIS has added another 573 items that will no longer be required to be registered prior to importation, distribution, or sale.

Most of the new products added to the list are considered low-risk items like patient positioning equipment, staining solutions, and artificial teeth, according to Emergo. This list also includes various hardware accessories for computers, like cables, along with automatic and manual patient beds.

While the move by COFEPRIS is a relaxation of regulation for certain products, it is not be confused with laxity on the part of the Mexican regulators. Properly identifying and labeling medical devices is an important part of importing into the country. Recently, it was reported by the Emergo Group that manufacturers that had failed to comply properly with Mexican regulations had been subject to confiscation of their products. This has recently resulted in literally millions of devices being confiscated. 

Interestingly, an area that COFEPRIS has not started to regulate is medical software, according to the blog. This is a significant difference between the Mexican regulatory environment and that of the United States. Currently, the FDA is highly focused on this area of medical device regulation and has recently issued a cybersecurity guidance document, according to a recent article on Med Device Online. Devices that incorporate software are potentially at risk from unauthorized changes if software is accessible, which could lead to increased patient risk.