International Programs
-
Training videos (Medical Devices)
Foreign Language Translation Inventory List [120 KB]The documents below are available in several foreign language(s). FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translation that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of these documents is the English version.
-
Español (Spanish)
La FDA ofrece esta traducción como un servicio para un amplio público internacional. Esperamos que encuentre útil esta traducción. Mientras que la agencia ha tratado de obtener una traducción lo más fiel posible a la versión en inglés, reconocemos que la versión traducida podría no ser tan precisa, clara o completa como la versión en inglés. La versión oficial de este documento es la versión en inglés.
-
-
中文 (Simplified Chinese)
美国食品药品管理局（FDA）提供此译文作为面向广大国际读者的一种服务。我们希望您觉得此译文对您有用。虽然本局努力获取尽可能忠于英文原文的译文，但是我们意识到译文不可能如英文原文那么精确、清楚或完整。本文件的正式版本是英文版。
-
-
English
- Medical Device Quality Systems
- Premarket Review Process for Medical Devices
Overview of Regulatory Requirements: Medical Devices
Investigational Device Exemption Process
Device Establishment Registration and Listing
Medical Device Software Regulation
Medical Device Recalls
- Medical Devices - Reports of Corrections and Removals
Medical Devices - MAUDE
- Medical Devices - Export Certificates
Medical Devices - Regulation of Radiation - Emitting Products: How to Get Your Electronic Product on the U.S. Market
Medical Devices - Single Audit Program: Quality Management System Audit Reports
- Bioresearch Monitoring (BIMO)
- BIMO Part 1b: Introduction to the Bioresearch Monitoring Program
- BIMO Part 2a: The Sponsor: Responsibilities in Medical Device Clinical Trials
- BIMO Part 2b: The Clinical Investigator: Responsibilities in Medical Device Trials
- BIMO Part 2c: Computerized Systems Used in Medical Device Clinical Investigations
- BIMO Part 3a: Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
- BIMO Part 3b: Institutional Review Board: Humanitarian Use Devices
- BIMO Part 3c: Institutional Review Board: Compassionate and Emergency Use
- BIMO Part 4a: Preparing for an FDA Medical Device Sponsor Inspection
- BIMO Part 4b: Preparing for an FDA Clinical Investigator Inspection
- BIMO Part 4c: Preparing for an FDA Institutional Review Board Inspection
- BIMO Part 5a: Strategies for Sponsors to Build Quality into Device Research
- BIMO Part 5b: Strategies for Clinical Investigators to Build Quality into Device Research
- Medical Device Reporting (MDR)
- Electronic MDR (eMDR)
- MDR for User Facilities
- MDR for Manufacturers and Importers
- Phantom Imaging Scoring
eSubmitter Tutorial Videos - Module 2 - Information about the Manufacturer
- Module 3 - Information about the Audit
- Module 4 - Audit Findings
- Module 5 - Conclusions
-
-
-
