課程介紹
歡迎來到「美國FDA醫療器材法規基礎」課程！您是否對醫療器材的合規性感到疑惑？是否想了解如何將醫療器材合法地引進美國市場？本課程將帶您一步步揭開FDA醫療器材法規的神秘面紗，深入淺出地講解各項規定和要求。
在這門課程中，您將了解什麼是醫療器材、為什麼它們需要符合法規、以及如何遵循這些法規。透過實例和案例分析，我們會讓複雜的法規變得簡單易懂。無論您是從事醫療器材行業的專業人士，還是對這個領域感興趣的學習者，這門課程都將是您不可或缺的指南。
Welcome to the “Fundamentals of FDA Medical Device Regulations” course! Are you puzzled by the compliance requirements for medical devices? Do you want to know how to legally bring medical devices into the US market? This course will take you step-by-step through the mysterious veil of FDA medical device regulations, providing a thorough yet easy-to-understand explanation of each requirement.
In this course, you will learn what medical devices are, why they need to comply with regulations, and how to follow these regulations. Through real-world examples and case studies, we will make complex regulations simple and understandable. Whether you are a professional in the medical device industry or an interested learner, this course will be your indispensable guide.
這門課程您會學到
- 醫療器材的定義和分類
- 為什麼醫療器材需要符合法規
- 如何將醫療器材進口到美國市場
- 美國FDA的歷史、結構和核心職責
- FDA法規的基本框架和主要法規
- 醫療器材的分類和分級
- 上市前法規概要
- 上市後法規概要
- 510(k)和PMA的區別與申請流程
- FDA品質系統法規的核心要素
- FDA官方網站的主要內容和資源
- 常見的FDA相關問題及解答
- 醫療器材法規的未來發展趨勢和挑戰
- 想銷售醫療器材到美國的途徑
What You Will Learn in This Course
- The definition and classification of medical devices
- Why medical devices need to comply with regulations
- How to import medical devices to the US market
- The history, structure, and core responsibilities of the US FDA
- The basic framework and main regulations of the FDA
- Classification and categorization of medical devices
- Overview of pre-market regulations for medical devices
- Overview of post-market regulations for medical devices
- Differences between 510(k) and PMA, and their application processes
- Core elements of the FDA quality system regulation
- Main contents and resources of the FDA official website
- Common questions and answers about the FDA
- Future development trends and challenges in medical device regulations
- Pathways to sell medical devices to the US
適合上這門課的人士
- 醫療器材行業的專業人士
- 合規與品質管理人員
- 有志於進入醫療器材領域的學生和研究者
- 對FDA法規和醫療器材感興趣的任何人
Who Should Take This Course
- Professionals in the medical device industry
- Compliance and quality management personnel
- Students and researchers interested in entering the medical device field
- Anyone interested in FDA regulations and medical devices
Course Features
- Lectures 3
- Quiz 0
- Duration Lifetime access
- Skill level Beginner
- Language 繁體中文 & English
- Students 0
- Certificate No
- Assessments Yes
Requirements
- 課前須知 • 本次活動為預錄影音，請學員依各自所需要的條文內容觀看每個單元，最後單元集合歷年來學長姐詢問的Q&A
- • 活動期間您可以在每天24小時彈性利用時間觀看所有影片，但請於規定的時間內完成收看所有單元，截止時間一到，系統自動關閉。
- • 每個單元（Q&A除外）都會有學習評量（Quiz）給學員作答。加總成績需答對至少（含）70%才算合格，在課後可自行下載結業證書電子檔。若成績不足70%，可選擇重考。
- • 請勿將影片連結及帳號密碼提供給您以外之任何人使用。
- • 每個單元的網頁都有提供大補帖供下載，但不提供簡報，重點都在影片中，請各位用心聽講，勤作筆記！
- • 上課前，請先下載課前大補帖（pre-study materials），並事先研讀，這樣在上課時可以事半功倍。
- • 這個課程的智財權屬FDAclass所有，請尊重講者勿錄影錄音，更不要再轉寄給其他未付費報名的同事或朋友，以保障其他學員的權益。
Features
- • 深入淺出的法規解析 o Clear and Simple Regulatory Analysis
- • 真實案例與實戰經驗分享 o Real-World Case Studies and Practical Experience Sharing
- • 專業講師帶領，權威知識 o Led by Professional Instructor, Authoritative Knowledge
- • 靈活的學習時間，隨時隨地學習 o Flexible Learning Schedule, Learn Anytime, Anywhere
- Expectata nihili faciliorem pomponius hoc hic possumus quicquam plus praestat cn etiamne iracundia
- Pellit futuri infelix epicuro potestne comitetur comparatur ingeniosi infima peripateticis gravis appellamus deprimet quando
- • 系統化的課程設計，全面覆蓋法規重點 o Systematic Course Design, Comprehensive Coverage of Regulatory Key Points
- • 學習評量與結業證書 o Learning Assessments and Completion Certificate
- • Q&A單元解答學員常見問題 o Q&A Unit Addressing Common Student Questions
- • 豐富的課前資料，幫助學員更好準備 o Rich Pre-Study Materials to Help Students Better Prepare
- 影片可回放，重複學習加深理解 Videos Can Be Replayed for Deeper Understanding
Target audiences
- • 醫療器材行業的專業人士 Professionals in the medical device industry
- • 合規與品質管理人員 Compliance and quality management personnel
- • 有志於進入醫療器材領域的學生和研究者 Students and researchers interested in entering the medical device field
- • 對FDA法規和醫療器材感興趣的任何人 Anyone interested in FDA regulations and medical devices
