This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada for obtaining a...
Resource Library for Medical Device Professionals
Resource Library for Medical Device Professionals
328 total results. Use the filters to narrow down the results.
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.
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
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
ISO 13485:2016: Six Key Differences for Medical Device Companies
This short video covers the 6 biggest changes in the new ISO 13485:2016.
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
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.
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.
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.
Canada
Health Canada Medical Device Regulations
A comprehensive list of medical device regulations in Canada with links to the original documents.
China | Medical Devices
NMPA - National Medical Products Administration
Learn about the regulatory structure in China and major medical device regulations.
China | Medical Devices
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
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
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.
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 – Overview of medical device industry and healthcare statistics
A brief look at China's medical device market, including potential opportunities and obstacles for manufacturers.
China | Medical Devices
China NMPA Medical Device Registration Requirements
This white paper discusses how to register your medical device in China.
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.
China | Medical Devices
China NMPA Medical Device Regulations
A comprehensive list of medical device regulations in China with links to the original documents.
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.
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
Colombia Medical Device Regulations
A comprehensive list of medical device regulations in Colombia with links to the original documents.
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.
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.
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.
Costa Rica
Costa Rica Medical Device Regulations
A comprehensive list of medical device regulations in Costa Rica with links to the original documents.
Egypt
Medical Device Consulting Services for Egypt
Interested in selling your medical device or IVD in Egypt? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.