Global Medical Device Standards

Regulation of medical devices is growing rapidly each year. As a result, it is important for organizations to familiarize themselves with the Global Medical Device Standards. Below are the links to the five countries or regions with the most advanced medical device regulations. 
Here is a partial Sampling of a key Medical Device Quality System and the Standards from around the world:

ISO Standards and Guides for the Medical Device Quality System

US FDA Medical Device Standards, Regulations & Guidelines 

European Medical Device Regulations Directives (MEDDEV):

Canadian Medical Device Regulations (CMDR)

Australian Medical Device Regulations (ARGMD)

Japanese Medical Device Regulations & Guidelines


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