US FDA updates list of standards used in premarket review
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration has updated the list of standards it recognises for use in the premarket review of medical devices1.
You may also be interested in...
Asia Regulatory Forum Update
Three upcoming medical device regulations were discussed at BSI’s Hong Kong Forum in April that will be important to the success of Hong Kong’s voluntary regulatory system, the Medical Device Administrative Control System.
Saudi Arabia adopts interim device authorisation regulation
Saudi Arabia has adopted an interim marketing authorisation regulation under which, possibly as early as 2010, only medical devices that have been approved by the Saudi Arabia Food and Drug Administration will be allowed on the market1. Additionally, only medical devices that comply with the regulations in force in the European Union, the US, Canada, Japan or Australia – ie in the jurisdiction of a Global Harmonization Task Force founding member - will be eligible for marketing in the country2,3.
Canada takes action to increase more adverse event reporting
The government of Canada has launched a marketing campaign to encourage consumers and healthcare professionals to use the country’s MedEffect initiative for reporting suspected adverse events related to healthcare products1.