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所在平台: Udemy |
课程主页: https://www.udemy.com/course/medical-device-registration-in-saudi-arabia/
课程评论：没有评论
课程名称：掌握沙特阿拉伯医疗器械注册 课程概述：本课程旨在帮助学员掌握在海湾合作委员会（GCC）地区最大市场——沙特阿拉伯进行医疗器械注册的知识。沙特市场对制药和医疗行业的从业者而言至关重要，市场潜力巨大，预计收益可观。 学习内容包括： - 医疗器械分类 - 医疗器械电子系统 - 医疗器械注册指导 - 沙特食品和药品管理局（SFDA）的提交要求 - 通知机构分类 - 注册表格模板 - 打包及打包图示 - MDMA（医疗器械市场准入）申请流程 - 验证与MDMA认证 - 清关及药物追踪 本课程将为学员提供进入制药行业的强大工具，学员将成为监管事务专业人士，掌握通过医疗器械注册为公司带来显著收入的能力。医疗器械的注册时间框架通常比药品短，注册仅需6个月，变更3个月和续期1至2个月，大大加快了产品上市和收益获益的速度。此外，医疗器械领域充满创新，相较于药品，市场潜力无限。 在课程中，学员将共同探索沙特阿拉伯的健康管理机构SFDA，了解注册、续期和变更的要求；研究实际表格和模板，准备提交材料及其验证；学习如何将多种医疗器械打包成一个MDMA申请；并与SFDA登记门户进行互动。最后，我们将深入了解清关程序、追踪系统和条形码技术在进口过程中的应用。 完成课程后，学员将熟练掌握沙特阿拉伯医疗器械注册的流程，期待在制药行业与大家相见。
Master medical devices registration in the most important and biggest market ever in the GCC region, the market of Sudi Arabia, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.What will you Learn?IntroductionMedical devices classificationMedical devices electronic systemGuidance on medical devices registrationSFDA submission requirements Notified body Classification Registration Forms Templates Bundling Bundling Diagrams MDMA Application process Verification MDMA certificationClerance and PVThis course will equip you with two powerful tools to invade the pharma industry, as a regulatory affairs professional you are responsible for bringing up to 80% if not 90% of the company revenue from only one market in the GCC region in one hand while in your other hand you are dealing with the second powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, it is almost half the time frame of the pharmaceuticals.To register a medical device, you will need only 6 months, 3 months for variation, and 2 to 1 month only for renewal.So, from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of the KSA.Daer pharma industry future professionals, let us start our interesting journey towards medical device registration in KSA, we will travel together in Saudia Arabia, meet the health authority there "SFDA", and explore its requirements for registration, renewal, and variations, let us get our MDMA and place our products there.In this course, we will cover all topics related to medical devices in the KSA, starting from the requirements, interim regulations, classification, verification, and special conditions.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 MDMA application, and interact with the actual SFDA gateway for MDMA submission. and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for KSA market importation. And finally, congratulations to you for mastering medical device registration in the KSA market and see you soon in the pharma industry my dear colleagues.
