The market and regulation of medical devices in Mexico

The market and regulation of medical devices in Mexico

Mexico is a country located in North America, neighboring the United States and the countries of Central America. It has more than 126 million inhabitants who have a public health system covered by the IMSS (Mexican Institute of Social Security) and a private system covered by private insurance plans or cash payments. Along with Brazil, Mexico ranks among the top 10 countries with the largest number of hospitals.

The medical device industry in Mexico is one of the most relevant globally, as the country is the 6th largest exporter and 10th largest importer worldwide. During 2020, Mexico exported $18.6 billion in medical products, of which Baja California (a Mexican state) contributed approximately 50%, maintaining its position as not only a national, but also a Latin American leader.

The Mexican domestic market, according to research conducted by the Massachusetts International Trade and Research Office, has a growing demand for products for the care of degenerative diseases, such as personal glucose and cholesterol monitors, glucose control products, massagers and weight control devices, as well as anesthesia and respiratory therapy equipment, cardiac simulators, defibrillators, diagnostic equipment, electrocardiographs, electro surgery devices, gamma X-ray equipment, incubators, laser surgical devices, MRI machines, suction pumps, ultrasound devices, and endoscopes.

Mexico has a very robust regulation of medical devices, which is regulated by COFEPRIS (Federal Commission for the Protection against Sanitary Risks), and has legislation that has been adapting to international medical device standards, as well as aligning with international regulatory harmonization.

Product registration in Mexico can be done through traditional entry or through an equivalence agreement that accepts FDA, Canada Health or Japan registration, called Fast Track, which results in faster and easier approval.

Caso possua interesse em registrar em um mercado tão promissor e abundante como o México, entre em contato com a Passarini Group! Iremos lhe auxiliar na obtenção de sua aprovação!

Mas se ainda ficou com dúvida, fale com os nossos especialistas através do e-mail: contato@passarini.com.br.

Passarini Group

Publicado em: 05/05/2023 – Fonte: AMID.ORG