Importing Medical Devices into Mexico
有任何问题？向我们的专家获取相关信息
联系我们
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:
- What is the Harmonized System code?
- What documentation is required with our shipments?
- Which import permit category should we pursue?
- What challenges could we face during the importation process?
Learn all this and more in this 7-page white paper.
About the Authors
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.
相关
-
韩国医疗器械法规框架及注册路径解读
我们的专家将详细解读2023年韩国食品药品安全部（MFDS）指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范（KGMP）等相关要求，并将依据多年韩国本地注册经验提供注册案例分享。此外，您还将了解到制造商在面对MFDS监管时需要关注的核心要点，相关研讨会内容包括：
阅读更多 -
IVDR过渡倒计时！欧盟体外诊断器械法规实施要点及合规挑战解析
新欧盟体外诊断器械法规（IVDR，In Vitro Diagnostic Device Regulation (EU) 2017/746）IVDR的发布为体外诊断器械医疗器械制造商满足欧洲市场合规带来新规实施、新旧过渡的诸多前所未有的挑战。对此，全球医疗器械及IVD器械合规专家Emergo b
阅读更多