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).