Mexico exempts hundreds of medical devices from registration
13-Jan-15, Med Device Online
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. 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.