Dear All
The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard.
The non-binding guidance document, N87: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (NCAs), was developed by GHTF's post-market surveillance and vigilance study group two (SG2) and released to the public on 1 August.
Source:
Raps [Regulatory Focus]
The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard.
The non-binding guidance document, N87: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (NCAs), was developed by GHTF's post-market surveillance and vigilance study group two (SG2) and released to the public on 1 August.
Source:
Raps [Regulatory Focus]
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