News/Blog

Medical Device Standard Transition Dates – IEC 60601 3rd edition

by G&M Compliance (May 2, 2013)

European Union (EU) General Standard June 1, 2012

European Union (EU) Particular Standards Varies*

Canada General Standard June 1, 2012

Canada Particular Standards Varies*

United States of America (FDA) July 1, 2013

Brazil Jan. 1, 2014

Japan Published June 1, 2012 *(Transition potentially 2017)

Taiwan & Singapore Recognize 3rd Edition, no transition date announced

Other Countries TBD

*Medical devices that fall within the scope of a particular standard are subject to various dates as noted by the Official Journal of the EU for EU and for Canada, a 3 year transition from the date of publication of the particular standard.

For more information, please contact G&M Compliance, Inc. at 714.628.1020