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The Learning Library for Medical Device & IVD Professionals

Our Learning Library contains a wealth of articles written by Emergo Group plus international medical device and IVD regulations and guidance documents. Most regulatory documents are in English. To stay current on the latest quality and regulatory issues facing the device industry, subscribe to our eJournal Update on international regulatory issues or visit our QA/RA blog.

Articles Written by Emergo Group on Quality Assurance and Regulatory Affairs


US Department of Commerce Overview of Medical Device Requirements

Argentina | Brazil | Canada | Chile | Columbia | Czech Republic | Egypt | India | Israel | Jordan | Malaysia | Mexico | Peru | Russia | Saudi Arabia | South Africa | South KoreaVenezuela | Vietnam

Links to 58 Ministry of Health Websites Worldwide


See PDF copies of medical device regulations published by:

AUSTRALIA - Therapeutic Goods Administration (TGA)

CANADA - Health Canada

CHINA - State Food and Drug Administration (SFDA)

EUROPE - Medical Devices Directives and other Directives/Documents

JAPAN - Ministry of Health, Labour and Welfare (MHLW) and the PMDA

UNITED STATES - Food and Drug Administration (US FDA)

 

 

 

Help us keep these files up to date. If you find a newer version of  a document, please email us at cs@emergogroup.com. Thanks.