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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

264 total results. Use the filters to narrow down the results.
Download the free chart: Australia Regulatory Approval Process for Medical Devices
Australia

Australia TGA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
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
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

Medical Device Consulting Services for Australia

Interested in selling your medical device or IVD in Australia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Varies
May 19, 2008
Australia

Medical Device Registration in Australia & New Zealand

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.

6 pages
Nov 12, 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
Fill out our short form to request information about Australia
Australia

Get smart about Australia in 1 hour

Thinking about entering the Australian market for the first time? Understanding the TGA's regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017
Learn about basic demographic and healthcare market data on Australia
Australia

AUSTRALIA – Overview of medical device industry and healthcare stats

A brief look at Australia's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Aug 28, 2014
Australia

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018
Australia

TGA - Australia Therapeutic Goods Administration

Learn about the regulatory structure in Australia and major medical device regulations.

1 page
Feb 10, 2014
Learn about the Australian TGA regulations which apply to medical devices
Australia

Australia TGA Medical Device Regulations

A comprehensive list of medical device regulations in Australia with links to the original documents.

Downloadable PDFs
Apr 14, 2008
Compare the time, cost and complexity of getting regulatory approval for medical devices
Australia

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015
Brazil

Brazil QMS Requirements For Medical Device Manufacturers

Thinking about selling your medical device in Brazil? This Brazillian market is complex but the sales potential is worth the effort.

9 pages
Apr 6, 2015
Brazil

Medical Device Registration Process in Brazil

Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but very complex. It's important to understand the process upfront to avoid delays down the road.

11 pages
Apr 12, 2017
Download the free chart: Brazil Regulatory Approval Process for Medical Devices
Brazil

Brazil ANVISA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Brazil ANVISA medical device approval process and includes a timeline of expected approval.

2 pages
Jul 21, 2016
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

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

Medical Device Consulting Services for Brazil

Interested in selling your medical device or IVD in Brazil? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Varies
Dec 23, 2009
Fill out our short form to request information about Brazil
Brazil

Get smart about Brazil in 1 hour

Thinking about entering the Brazilian market for the first time? Understanding the ANVISA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017
Brazil

Overview of the IVD Regulatory Landscape in Brazil

In this white paper, learn about recent changes to the regulatory process for IVDs in Brazil.

7 pages
Dec 14, 2016
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
Brazil

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018
Learn about basic demographic and healthcare market data on Brazil
Brazil

BRAZIL – Overview of medical device industry and healthcare statistics

A brief look at Brazil's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Sep 16, 2013
Brazil

ANVISA - Brazil National Health Surveillance Agency

Learn about the regulatory structure in Brazil and major medical device regulations.

1 page
Feb 7, 2014
Compare the time, cost and complexity of getting regulatory approval for medical devices
Brazil

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015
Canada

Health Canada: Structure and Overview

Learn about the regulatory structure in Canada and major medical device regulations.

1 web page
Feb 10, 2014
Canada

Preparing a Canadian MDL Application

This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k).

17 pages
Oct 7, 2015
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
Download the free chart: Canada IVDs Regulatory Approval Process for Medical Devices
Canada

Health Canada Regulatory Approval Process for IVDs

This chart illustrates the steps in the Health Canada IVD approval process and includes a timeline of expected approval.

2 pages
Aug 10, 2016
Canada

Achieving QMS Compliance for Canada Beyond ISO 13485

An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).

6 pages
Sep 16, 2016
Fill out our short form to request information about Canada
Canada

Get smart about Canada in 1 hour

Thinking about entering the Canadian market for the first time? Understanding the Health Canada regulatory requirements can be confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017
Canada

Medical Device Consulting Services for Canada

Interested in selling your medical device or IVD in Canada? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Varies
May 19, 2008
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
Learn about Health Canada
Canada

List of Registrars Recognized by Health Canada

Health Canada will only accept quality system certificates which have been issued by CMDCAS recognized registrars.

1 web page
Aug 28, 2014