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Resource Library for Medical Device Professionals

17 total results. Show all resources.
Canada

Health Canada: Structure and Overview

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

1 web page
Feb 10, 2014
Download the Chart on the Medical Device Approval Process in Canada
Canada

Health Canada Regulatory Approval Process for Medical Devices

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

2 pages
Aug 10, 2016
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

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
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.

1 hour
Aug 1, 2018
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

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

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
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
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

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 the Health Canada regulations which apply to medical devices
Canada

Health Canada Medical Device Regulations

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

Downloadable PDFs
Apr 14, 2008
Canada

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 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
Learn about basic demographic and healthcare market data on Canada
Canada

CANADA – Overview of medical device industry and healthcare statistics

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

1 web page
Aug 28, 2014
Compare the time, cost and complexity of getting regulatory approval for medical devices
Canada

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