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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.
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).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

China | Medical Devices

NMPA - National Medical Products Administration

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

Download the free chart: China Regulatory Approval Process for Medical Devices
China

China NMPA Regulatory Approval Process for Medical Devices

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

China

Medical Device Consulting Services for China

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

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

Fill out our short form to request information about China
China

Get smart about China in 1 hour

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

Learn about the Chinese CFDA regulations which apply to medical devices
China | Medical Devices

China NMPA Medical Device Regulations

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

China | Medical Devices

China NMPA Medical Device Registration Requirements

This white paper discusses how to register your medical device in China.

China

CHINA – Overview of medical device industry and healthcare statistics

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

Compare the time, cost and complexity of getting regulatory approval for medical devices
China

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.

Download the free chart: Colombia Regulatory Approval Process for Medical Devices
Colombia

Colombia INVIMA Medical Device Regulatory Approval Process

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

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.

Colombia

Medical Device Consulting Services for Colombia

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

Compare the time, cost and complexity of getting regulatory approval for medical devices
Colombia

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.

Colombia

INVIMA - Colombia National Food and Drug Surveillance Institute

INVIMA is in charge of providing medical approval for the import and export of products, including medical devices. The regulatory authority was created in 1992 under the Ministry of Health of Colombia. Learn more about the agency.

Learn about the Colombian INVIMA regulations which apply to medical devices
Colombia

Colombia Medical Device Regulations

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

Download the Chart on the Medical Device Approval Process in Costa Rica
Costa Rica

Costa Rica medical device approval process

This chart illustrates the steps in Costa Rica's medical device approval process and includes a timeline of expected approval.

Costa Rica

Medical Device Consulting Services for Costa Rica

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

Compare the time, cost and complexity of getting regulatory approval for medical devices
Costa Rica

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.

Costa Rica

Costa Rica Ministry of Health Overview

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