The Emergo Group Learning Library
The Emergo Learning Library contains a wealth of articles written by Emergo Group plus medical device regulations and guidance documents from around the world. To stay current on the latest quality and regulatory issues facing the device industry, subscribe to our eJournal Update on international regulatory issues.
Articles on Quality Assurance and Regulatory Affairs
Informative articles on quality assurance and regulatory issues written by Emergo Group.
Medical Device Regulations - AUSTRALIA
Regulations published by Australia's Therapeutic Goods Administration (TGA).
Medical Device Regulations - CANADA
Regulations governing devices published by Health Canada.
Medical Device Regulations - CHINA
English language translations of selected regulations for medical devices issued by the SFDA.
Medical Device Regulations - EUROPE
Medical Devices Directives and MEDDEV Guidance documents for Europe.
Medical Device Regulations - JAPAN
List of Ordinances and Notifications from the Ministry of Health, Labour and Welfare (MHLW).
Medical Device Regulations - USA
Regulations for medical devices published by the US Food and Drug Administration (FDA).