As technology improves and the scientific community discovers more ways to treat diseases, medical devices have become an increasingly common presence in many people’s lives. Because of this, it has become just as necessary to ensure that every device meets high standards for quality and integrity. As a result, manufacturers often use leak testing services, such as vacuum leak detection equipment, to meet strict requirements set by national governments. However, regulators in Mexico recently increased the number of medical devices and health products that do not require registration, a change that could impact the way a number of manufacturers conduct their operations.
Mexico is the second largest medical device market in Latin America after Brazil, making it an appealing opportunity for many businesses. The country divides medical devices into four classes based on their risk level, beginning with Class I devices, which are defined as “low risk”. However, Mexico’s medical regulation administration, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), also maintains a list of items that it does not consider to be medical devices. The group recently added 573 items to this list, no longer requiring them to be registered before being imported, distributed or sold.
Despite its connotations, experts say that the change should not be viewed as an example of lax judgement. The majority of the new products added to the list were previously considered low-risk items, such as patient positioning equipment, staining solutions, artificial teeth, computer cables, and automatic and manual patient beds. Few, if any, of the 573 items would require quality assurance methods like vacuum leak detection equipment.
The deregulation is part of a continuing process in Mexico’s healthcare field to properly identify and label devices that are being brought into the country. In a recent incident, a number of manufacturers that had failed to comply with COFEPRIS’s regulations had their imports confiscated, resulting in the loss of millions of devices. Due to the stridency of this environment, many companies seeking to conduct business in Mexico will need to do all that they can to prove the integrity, quality and legality of their products. With such a high-profit market at stake, these attempts could be well-worth the effort.