By Stewart Eisenhart, Emergo Group
Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.
By Stewart Eisenhart, Emergo Group
Canada’s medical device market regulator Health Canada has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications.
By Stewart Eisenhart, Emergo Group
Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According to Emergo’s Tokyo office.
By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulator ANVISA has begun allowing automatic extensions for deadlines for market registrants to comply with new requirements issued by the regulator.
By Stewart Eisenhart, Emergo Group
As many mobile medical application developers are aware, Apple has amended its App Store Review Guidelines to forbid apps available through the firm’s HealthKit framework from storing users’ health data on the iCloud virtual server.
By Stewart Eisenhart, Emergo Group
The Australian Department of Health has published additional details on the government’s plan to allow domestic medical device manufacturers to leverage CE Marking for faster registration in their home market.
By Stewart Eisenhart, Emergo Group
The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.
By Stewart Eisenhart, Emergo Group
By Stewart Eisenhart, Emergo Group
Emergo colleagues in China have provided additional analysis of new requirements from the China Food and Drug Administration (CFDA) regarding in vitro diagnostic (IVD) device registrations.
According to CFDA Administrative Order No. 5, all Class I, II and III IVDs imported into China will have to undergo new CFDA registration requirements beginning October 1, 2014.
By Stewart Eisenhart, Emergo Group