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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

326 total results. Use the filters to narrow down the results.
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Australia

TGA - Australia Therapeutic Goods Administration

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

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.

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.

Brazil registration webinar 2018
Brazil

WATCH NOW: Brazil ANVISA Medical Device Registration

In this free webinar, we discuss how to register your medical device with ANVISA and recent regulatory changes in Brazil.

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.

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.

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.

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.

Download the free chart: Brazil IVDs Regulatory Approval Process for Medical Devices
Brazil

Brazil ANVISA Regulatory Approval Process for IVDs

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

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.

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.

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.

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.

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.

Learn about the Brazilian ANVISA regulations which apply to medical devices
Brazil

Brazil ANVISA Medical Device Regulations

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

Brazil

ANVISA - Brazil National Health Surveillance Agency

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

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.

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.

Canada

Health Canada: Structure and Overview

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

WATCH NOW: Overview of the MDSAP Certification Process
Canada | Medical Devices

WATCH NOW: Overview of the MDSAP Certification Process

In this one-hour webinar, you will learn what it takes to obtain MDSAP certification from two of Emergo's QMS consultants.

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).

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.