|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-devices-registration-in-kingdom-of-bahrain/
课程评论：没有评论
## 课程总结：掌握巴林医疗器械注册 本课程旨在帮助您深入了解和掌握在巴林王国进行医疗器械注册的整个流程和关键环节。 尽管巴林市场规模相对较小，但它充满了机遇，尤其是在医疗器械领域。 **您将学到：** * **巴林国家卫生监管局（NHRA）的医疗器械制度** * **NHRA的医疗器械分类方法** * **NHRA的最新通告和相关法规** * **NHRA的注册工作流程和申请流程** * **医疗器械的捆绑（Grouping）原则** * **注册文件的准备（Dossier Preparation）** * **质量保证（Quality Assurance）和文件验证（Verification）** * **注册的更新（Renewal）、变更（Variation）及其各种类型** * **医疗器械的标签（Labeling）要求** * **NHRA的进口流程** * **NHRA的药物警戒（Pharmacovigilance）系统** 课程将以**“源于实践”**为主题，通过实际案例，带您进行一次实践性的学习旅程。课程内容涵盖了注册、更新、变更等各个方面。 **课程亮点：** * **深入市场分析：** 课程将对比巴林与其他海湾合作委员会（GCC）国家（如沙特阿拉伯和阿联酋）的市场状况，分析巴林市场在医疗器械领域的巨大机遇，以及如何抓住这些机遇，获得可观的市场份额。 * **实践操作指导：** 您将学习如何准备提交文件（dossier），共同完成文件的提交，并了解如何在实际系统中进行操作。 * **关键环节详解：** 课程将详细讲解医疗器械的捆绑/分组标准，确保将多个产品归入一个注册申请。 * **进口与供应链：** 课程将涵盖进入巴林海关清关、追踪/溯源系统、条形码和2D矩阵的应用，为您的产品顺利进入市场做好准备。 **课程价值：** 完成本课程后，您将拥有在巴林市场进行医疗器械注册的专业知识和实践技能，为您的职业发展或公司业务拓展奠定坚实基础。
Master medical devices registration in one of the most interesting parts of the GCC countries, a relatively small market, mainly driven by the market, full of opportunities, let's grape the opportunity and place our medical devices there in the market of the Kingdom of Bahrain.What will you learn?Introduction to NHRA medical devices system NHRA medical devices classification NHRA Circulars NHRA Workflow NHRA Application Process Bundling Process Dossier preparationQuality Assurance Verification Renewal variation LabelingNHRA Importation process NHRA Pharmacovigilance system In this course, I will take you on an interesting journey with the Ministry of the health of Bahrain, to master our medical devices registration there, let's practice regulatory affairs, registration, renewal, and variations with all its types, classification, case by case using actual examples from practice. As I always keep my theme in the pharma academy "It comes to you from practice"The market of the kingdom of Bahrain is quite small compared to other GCC markets, which are actually saturated with most of the kinds of products, such as the leader of the region "KSA" and the gulf region business hup "UAE", which means there is a huge opportunity waiting for us there, to master the market and have quite a big market share, especially with medical devices, due to the continuous innovations of the medical devices, and do not forget about the tenders, they are basic market players in all GCC countries markets.In this course, we will cover all topics related to medical devices in Bahrain, which will empower you to master the market. Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, budling /grouping criteria of the medical devices in only one application, and interact with the actual system for the submissionand we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for the kingdom of Bahrain market importation.The system was first implemented by KSA the leader of the region, and then Oman, UAE, and Bahrain followed so far, and the others are coming soon.And finally, congratulations to you for mastering medical device registration in the Bahrain market and see you soon in the pharma industry my dear colleagues.
