GHTF Issues Draft Guidance Document on UDI System for Medical Devices

bio_subbu

Super Moderator
#1
Dear All

The Global Harmonization Task Force (GHTF) Ad Hoc Working Group (AHWG) has published a draft guidance document GHTF/AHWG(PD2)/N2R2Unique Device Identification (UDI) System for Medical Devices” on 22 November 2010. The purpose of the UDI system is to improve patient safety by:

- facilitating traceability of devices

- enhancing the identification of devices in case of adverse events,

- assisting in the event of a field safety correction

To obtain the proposed document, refer GHTF website.
 

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Elsmar Forum Sponsor
#2
Hi all,

Yeap... This will also gonna be implement and enforce by the US FDA soon. The healthcare industry including the medical device manufacturer need to be ready for the implementation.

Tiff
 
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