Resource Library for Medical Device Professionals

16 total results. Show all resources.

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

Market Data | 1 web page

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

White Paper | 17 pages

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

Process Chart | 2 pages

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

Process Chart | 2 pages

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

Video | 4 minutes

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.view all

Service Overview | Varies

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

White Paper | 6 pages

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

Video | 22 minutes

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.view all

Market Data | 1 page

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

Video | 5 minutes

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all

 

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

Device Regulation | Downloadable PDFs

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

White Paper | 8 pages

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

Market Data | 1 web page

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

Market Data | 1 web page

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

Process Chart | Interactive Page