Enjoy our Second global standards & regulatory update. It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition
SFDA (China) Announces 17 New Device Classifications
The RAPS Regulatory Focus on 21 December 2012 posted an article in regard to the SFDA announcing 17 new device classifications. Click here to read the complete article.
GHTF has transitioned to IMDRF
As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
China SFDA’s Management Center for Medical Device Standards Unveiled
China SFDA’s Management Center for Medical Device Standards Unveiled http://eng.sfda.gov.cn/cmsweb/webportal/W43879541/A64031513.html