The safety and effectiveness of medical devices are of utmost importance, and continuous monitoring is essential to ensure successful regulation. Techno-vigilance serves as a vital system for identifying and evaluating adverse events related to medical devices.
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.
Medical devices in Mexico are regulated by the Secretariat of Health (Secretaría de Salud). Article 262 of the Mexican General Health Law requires all medical devices to be registered with the Secretariat of Health before being placed in Mexico. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) oversees the registration process of healthcare products. The Regulatory structure is composed of mandatory standards that are known as Normas Oficiales Mexicanas (NOM) and voluntary standards that are known as Normas Mexicanas (NMX).
Mexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America. The Medical devices marketed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), and the regulations are both stringent and complex.
Mexico is considered as the second largest market for medical devices in Latin America. In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health, regulates the Medical Device registrations and related services. Through sanitary regulations, control and promotion under a single command, the Agency aims to protect the population against sanitary risks posed by ineffective and unsafe devices.
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
The Mexican Regulatory Authority, COFEPRIS (The Federal Commission for Protection against Sanitary Risk) has established a new electronic appointment system for medical device registrants for submitting applications or seeking in-person meetings with the Agency. This measure is a part of the digitization process and in compliance with the provisions of the Ministry of Health, to limit the number of visitors to the COFEPRIS facilities and reduce the risk of contagion by COVID-19.
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.
