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Policy & Regulation - Vigilance
US FDA invites comments on introducing UDIs in electronic data healthcare systems
26 July 2011
The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems. Implementing UDIs in ...
China issues interim provisions on device recalls
22 June 2011
China's State Food and Drug Administration has promulgated interim provisions relating to its management of the medical device recall process. The new provisions, comprising six chapters and 38 articles, are due to come into effect on 1 July. The ...
ISO issues new testing standard for eye & skin reactions
13 October 2010
The International Organization for Standardization has published a testing standard for checking the safety of medical devices prior to their marketing and use to ensure they do not irritate the skin or eyes, or cause other adverse reactions. The ...
Tanzania issues consultation on device permits and GDP requirements
12 October 2010
The Tanzanian Food and Drugs Authority has issued two complementary draft guidelines to further the implementation of its new medtech regulatory framework. The first draft document describes the agency's processes and procedures for issuing licence ...
Swiss/New Zealand collaborate on market control 20 October 2009

The Swiss Agency for Therapeutic Products, Swissmedic , and the New Zealand Medicines and Medical Devices Safety Authority, Medsafe have signed an agreement to collaborate more closely in the field of therapeutic products, including medical ...

 
Heart Rhythm Society calls for more stringent pre- and postmarketing studies of heart wires
15 May 2009
Following well-documented problems with lead wires for heart devices, a Heart Rhythm Society task force has issued the first comprehensive guidance on their performance. Among its recommendations were calls for more thorough premarket evaluation – ...
 
 
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