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市場調查報告書

醫療設備的美國市場的法規相關資訊

Regulatory Intelligence Report for Medical Devices in the U.S.

出版商 BCC Research 商品編碼 926690
出版日期 內容資訊 英文 11 Pages
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價格
醫療設備的美國市場的法規相關資訊 Regulatory Intelligence Report for Medical Devices in the U.S.
出版日期: 2020年02月26日內容資訊: 英文 11 Pages
簡介

本報告提供美國的企業及在美國計劃醫療設備的製造,流通,銷售的外國企業或公司所在地的法規與必要條件的相關調查,設施或醫療設備的登記相關的相關法規,設備的分類地簡單說明。

第1章 簡介

  • 調查目標、目的
  • 調查範圍
  • 資訊來源
  • 分析師的經歷
  • BCC Research的相關報告

第2章 政府機關、分類

  • 法規當局
  • 醫療設備的定義與分類

第3章 法規

  • 聯邦規則集(CFR)
  • eCFR
  • 市售前通知510(k)淨空
  • 510(k)免除設備
  • PMA(市售前核准)
  • Good Manufacturing Compliance(GMP)遵守
  • 成立登記
  • 設備的登記和清單
  • 標籤必要條件
  • 廣告
  • 醫療設備報告(MDR)
  • 當地代理商的必要條件
  • 美國代理店的責任
  • 醫療設備使用費
目錄
Product Code: MDS006A

Report Highlights:

The goals of this study were to understand the regulations and requirements of the companies in the US and the foreign companies or establishments planning to manufacture, distribute or market their medical devices in the US. This report provides a brief about the related regulation for registration of the establishments or medical devices along with the classification of the devices.

Report Includes:

  • Detailed description of the regulatory requirements for marketing and registration of medical devices in the U.S.
  • Insights into the current regulations and comprehensive procedures for the registration, renewal or notification of the medical devices, along with the information on timeline and fee required
  • Knowledge about labelling and advertising regulations for the medical device and details of the process for registration of the product with any specific variation
  • Information on Federal Food, Drug, and Cosmetic Act (the Act) and how it works towards the betterment of society

Table of Contents

Chapter 1: Introduction

  • Study Goals and Objectives
  • Scope of Report
  • Information Sources
  • Analyst's Credentials
  • Related BCC Research Reports

Chapter 2: Governing Authority and Classification

  • Governing Regulatory Authority
  • Medical Device Definition and Classification

Chapter 3: Regulations

  • Code of Federal Regulations (CFR)
  • eCFR
  • Premarket Notification 510(k) Clearance to Market
  • 510 (k) Exempt Devices
  • PMA (Pre-Market Approval)
  • Good Manufacturing Compliance (GMP) Compliance
  • Establishment Registration
  • Device Registration and Listing
  • Labelling Requirement
  • Advertising
  • Medical Device Reporting (MDR)
  • Local Agent Requirements
  • Responsibilities of the US agent
  • Medical Device User Fee

List of Tables

  • Table 1: Class I and Class II Exempt Devices
  • Table 2: Medical Device User Fee Amendments (MDUFA)-2020

List of Figures

  • Figure 1: Process for Marketing the Medical Device in the US Market