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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-devices-registration-united-arab-emirates/
课程评论：没有评论
**课程名称：** 阿联酋医疗器械注册大师 **课程概述：** 本课程将带您深入探索中东地区充满活力的医疗器械市场，聚焦于商业枢纽——阿拉伯联合酋长国，特别是迪拜。您将全面了解在该极具吸引力市场中医疗器械准入的各项事宜。 **学习内容：** * 医疗器械分类 * 分类规则与文件 * 制造商质量合规性（ISO 13485） * 欧洲CE认证 * 2011年版（现仍有效）的医疗器械注册指南 * 整体注册流程图 * 注册提交文件（Dossier）构建 * 文件清单、表格及模板准备 * 高风险医疗器械的“药物类似剂型”概念及处理方法 * 注册续期流程及图示 * 阿联酋卫生与预防部最新通告 **课程亮点：** 本课程旨在成为您在阿联酋成功注册和推广医疗器械的全面指南。从医疗器械分类的基石，到制造商的质量证明，再到具体的注册流程和文件准备，每一步都将为您清晰讲解。您将学习如何构建注册提交文件，理解不同风险级别的器械注册要求，并了解注册后的续期流程。课程结构清晰，步骤明确，助您顺利完成整个注册过程。
In this course, I will take you through an interesting journey towards the highly dynamic market in the middle east region, we will fly together to the business hub of the middle east region, we will travel to the United Arab Emirates, and we will go to Dubai and learn everything about medical devices placing in this highly interesting market.What will you learn?Introduction Medical devices classification Clarification rules and documents Manufacture Quality Marketing Authorization Medical devices registration guidelines Site Dossier Registration Checklist Summary of registration process RenewalsForms Closing This course will lead you from the start to the end of the process of placing medical devices in the market of the United Arab Emirates, we will explore together all aspects related to the regulatory activities and tools that help us to place our medical devices in a such dynamic market. This course is structured to act as a guide or a manual that you just have to follow step by step that will lead you smoothly towards the whole process. We will start with classification as the usual basic backbone step towards any product registration in any countrywe will go through the classification guidelines and match them with the 3 basic classes of medical devices, normal medical devices, in-vitro medical devices, and active medical devices.Then will move to the manufacturer, along with its proof of quality compliance, which is the ISO 13485, and then will explore together the different CE certificate approvals in Europe.Then we will dive deeper into the medical devices Registration Guidance issued in 2011, and still valid now.We will stop at the flow chart of the whole process of medical device registration in the UAE. And then we will use all these tools to build up our submission dossier, will go through the document's checklist, forms, and templates, and prepare them.We will explain the term"Pharmaceutical Like Dosage Forms" for high-risk classes of medical devices, and how to deal with such a situation.And then will close the course with the renewal and its flow chart, in addition to the updated circulars issued by the Ministry of Health and Prevention of the United Arab Emirates.I hope that you enjoyed the flight.
