Who is the head of COFEPRIS?
Sánchez y Tépoz
Sánchez y Tépoz was appointed Head of COFEPRIS by the Mexican President, Enrique Peña Nieto, and acted as such until 2018. He initially joined COFEPRIS in 2011 as Chief of Staff for the Federal Commissioner, and in July 2012 he became Commissioner of Health Promotion.
What is COFEPRIS Mexico?
COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) is the department within the agency that deals with the importation of medical devices and issues advertising permits for these products.
What is FDA equivalent in Mexico?
COFEPRIS
The FDA and the agencies responsible for food safety regulation in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) – have a long history of working together.
Who regulates medical devices in Mexico?
Medical Devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency classifies Medical Devices into six different groups depending on their function and purpose: Diagnostic Agents.
What Mexican entity has final approval authority of financial laws in Mexico?
All financial regulation in Mexico is conducted at the federal level and overseen by the Secretaría de Hacienda y Crédito Público (SHCP), Mexico’s Finance Ministry, which is actually the highest authority within the structure of the Mexican financial system.
Does Mexico have a Food and Drug Administration?
COFEPRIS stands for Comisión Federal para la Protección contra Riesgos Sanitarios: Federal Commission for Protection against Sanitary Risks and is the authority with competence to control and regulate drug products in Mexico.
Does Mexico have a health department?
The Secretariat of Health (Spanish: Secretaría de Salud) is the government department in charge of all social health services in Mexico, and an integral part of the Mexican health system. The Secretary of Health is a member of the Executive Cabinet and is appointed at the discretion of the President of the Republic.
How do I register my medical device in Mexico?
All medical device registration licenses in Mexico are valid for 5 years, and all documents regarding medical device registration must be submitted in Spanish. For foreign manufacturers looking to market their devices in Mexico, appointing a local representative to handle registration is a requirement.
What does the PMDA do?
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.