Mexico: Medical device confiscation in the informal market was a record in 2016

Health surveillance of medical devices by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) began in 2013 and since then 9 million medical device units have been seized.

2016 recorded the highest number of confiscations with 6.8 million medical devices. Condoms were the main units seized in the informal market. Other medical devices confiscated included surgical materials, healing materials, medical equipment and diagnostic agents such as needles, catheters, syringes, probes, cannulae and scalpel.

The seized products were those which did not comply with good manufacturing practices, conditions of registration, labeling, or unstable. The Commission also reported that highest number of confiscations were from Jalisco, Mexico City, State of Mexico, Oaxaca and Nuevo León.

Among the products seized by COFEPRIS the highlighted ones this year were the ~47,000 HIV test kits made in China that can give false negative results. The Commission said that these rapid test kits have no health records and could endanger the health of patients who have not received the required medical treatment. The regulatory agency seized a government warehouse in the state of Veracruz which was accused of supplying counterfeit medicines to state hospitals.

COFPRIS announced new rules of classification of medical devices will be published in April this year in the Official Gazette of the Federation. The agency plans to deregulate 701 products that do not require sanitary registration or are low risk. The new rules of classification of medical devices will be decided under three agencies namely the COFEPRIS, the Mexican Association of Innovative Industries of Medical Devices and the National Chamber of the Cosmetic Products Industry. Since 2015, 2,242 medical devices have been deregulated as they no longer pose a health risk.

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