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Resource Library for Medical Device Professionals

45 total results. Show all resources.
Learn about how to get your device approved in Australia
Australia

In Depth: Australia medical device approval and compliance

This video series about the Australia medical device market shows you the process and identifies the key concepts to know before you begin.

16 minutes
Apr 27, 2015
Whatch this Short Video: Introduction to Australia's medical device approval process
Australia

Introduction to Australia's Medical Device Approval Process

This video about the Australia medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Apr 29, 2014
Australia

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch this Short Video: Introduction to Brazil's medical device approval process
Brazil

Introduction to Brazil's Medical Device Approval Process

This video about the Brazil medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Sep 26, 2014
Brazil

In Depth: Brazil Medical Device Approval and Compliance

This video series about the Brazil medical device market shows you the process and identifies the key concepts to know before you begin.

14 min
Jan 8, 2015
Brazil

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch this Short Video: Introduction to Canada's medical device approval process
Canada

Introduction to Canada's medical device registration process

This video about the Canada medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Mar 27, 2014
Canada

In Depth: Canada Medical Device Approval and Compliance

This video series about the Canada medical device market shows you the process and identifies the key concepts to know before you begin.

22 minutes
Dec 14, 2011
This short video describes the six biggest changes in ISO 13485:2016.
Canada

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

5 minutes
Jun 27, 2017
Watch our short video about registering your device in China
China

China Medical Device Market Overview

China has one of the world's largest medical device markets. Medical device manufacturers see sales opportunities in China, but the regulatory process can be challenging. Interested in learning how to tap into this market? Th

4 min
Mar 27, 2014
Watch this Short Video: Introduction to Colombia's medical device approval process
Colombia

Introduction to Colombia's Medical Device Approval Process

This video about the Colombia medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Oct 23, 2015
This short video describes the six biggest changes in ISO 13485:2016.
Europe

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

5 minutes
Jun 27, 2017
Europe

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch this Short Video: Introduction to Europe's medical device approval process
Europe

Introduction to European CE Marking for medical devices

This video about provides an overview of the regulatory framework and registration process basics for devices.

4 minutes
Sep 21, 2011
Whatch this Short Video: Introduction to ISO 13485 in the EU
Europe

Introduction to ISO 13485 compliance for Europe

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.

29 minutes
Nov 9, 2015
Watch this Short Video: Introduction to Europe's CER
Europe

Introduction to Clinical Evaluation Reports (CER) for Europe

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.

4 minutes
Mar 15, 2016
Watch our video about Medical Device Labeling Symbols
Europe

Introduction to Medical Device Labeling Symbols

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.

11 min
Nov 23, 2015
Europe

In-Depth: Europe CE Marking Medical Device Approval and Compliance

This video series about the European medical device market shows you the process and identifies the key concepts to know before you begin.

21 minutes
Feb 8, 2012
Israel

Introduction to the Israel AMAR Medical Device Registration Process

This short video covers how to register your medical device with AMAR in Israel.

6 minutes
Dec 13, 2017
Watch this Short Video: Introduction to Japan's medical device approval process
Japan

In Depth: Japan Medical Device Approval and Compliance

This video series about Japan's medical device market shows you the process and identifies the key concepts to know before you begin.

17 minutes
Apr 4, 2012
Watch this Short Video: Introduction to Japan's medical device approval process
Japan

Introduction to Japan's Medical Device Approval Process

This video about Japan's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Jul 24, 2014
Japan

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch this Short Video: Introduction to Malaysia's medical device approval process
Malaysia

Introduction to Malaysia's medical device approval process

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Aug 27, 2015
Mexico

In Depth: Mexico Medical Device Approval and Compliance

This video series about Mexico's medical device market shows you the process and identifies the key concepts to know before you begin.

16 minutes
Jun 19, 2015
Watch this Short Video: Introduction to Mexico's medical device approval process
Mexico

Introduction to Mexico's medical device approval process

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Jul 24, 2015
Mexico

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch our short video about Russia medical device approval and compliance
Russia

Introduction to Russia's Medical Device Approval Process

Russia is a promising market for medical devices, but the regulatory process can be challenging. Learn what's involved in this short video.

6 minutes
May 5, 2017
Watch this Short Video: Introduction to Saudi Arabia's medical device approval process
Saudi Arabia

Introduction to Saudi Arabia's Medical Device Approval Process

This video about Saudi Arabia's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
May 27, 2015
Watch this Short Video: Introduction to Singapore's medical device approval process
Singapore

Introduction to Singapore's Medical Device Registration Process

This video about Singapore's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Feb 9, 2015
Watch this Short Video: Introduction to South Korea's medical device approval process
South Korea

Introduction to South Korea Medical Device Approval Process

This four minute video provides an overview of South Korea's medical device registration process.

4 minutes
Sep 26, 2015
South Korea

In Depth: South Korea Medical Device Approval and Compliance

This video series about South Korea's medical device market shows you the process and identifies the key concepts to know before you begin.

15 minutes
Apr 7, 2015
South Korea

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Watch this Short Video: Introduction to Taiwan's medical device approval process
Taiwan

Introduction to Taiwan's Medical Device Approval Process

This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Apr 24, 2015
Watch our short video about Taiwan medical device approval and compliance
Taiwan

In Depth: Taiwan Medical Device Approval and Compliance

This video about the Taiwan medical device market shows you the process and identifies the key concepts to know before you begin.

10 minutes
Feb 16, 2017