Mexico is one of the largest importers and a remarkable manufacturer of medical devices in the world and specifically gripping in Latin America. Mexico, offering an attractive market for foreign companies, is ministered by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the Regulatory Body of the Mexican Government. In April 2022, COFEPRIS announced new rules for medical device submission.

The medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). There are different Regulatory pathways for the registration of medical devices in Mexico. Manufacturers may opt for Standard Review or Equivalency Review and may or may not opt for the third-party Reviewer.

Mexican Medical Device market is expected to reach $6.5 billion by 2020. Being the second largest market for medical devices in Latin America, Mexico offers a good bet of business opportunities. However, to market the devices in the region, manufacturers need to follow certain standards and procedures and should perform a clear-cut mapping of organizational goals and capabilities with that of Mexico’s regional Regulatory requirements.