The COFEPRIS registration process is complete and you are clear to sell your medical device or IVD in Mexico. But there is still plenty of paperwork ahead of you. Mexico's importation process comes with plenty of challenges. If you don't follow the appropriate procedures, you could encounter expensive delays and customs issues.
This white paper explores Mexico's importation process in greater detail. We'll answer your biggest questions about how to smoothly and successfully import medical devices to Mexico, including:
Learn all this and more in this 7-page white paper.
Eduin Matus Matíaz
is the Regulatory Affairs Manager for Emergo's office in Mexico City. With more than seven years of experience in the field of regulatory affairs for drugs and medical devices, his expertise includes registration submissions for medical devices before COFEPRIS, alongside strategic consulting for importing, registering, and distributing these products in Mexico.
Pedro Omar Sánchex Neri
is Operations Manager for Emergo's office in Mexico. With more than five years of experience in regulatory affairs, his areas of expertise include medical device and consumer products regulation in Mexico and Latin America. Mr. Sánchez has chemical engineering and chemical science studies from the Universidad Nacional Autónoma de México.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多要在欧盟合法销售体外诊断器械(IVD),您需要拥有证明其符合IVD法规的CE标识。CE标志表明合法制造商已经评估了器械,并且器械符合体外诊断器械指令98/79/EC(IVDD)的基本要求或体外诊断器械法规2017/746(IVDR)的一般安全和性能要求。合法制造商将验证它的器械是否符合所有相关
阅读更多