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Regulatory & Policy

01 Sep 2013
News US FDA Updates Plans for UDI and Post-Market Surveillance System
05 Apr 2013
News IMDRF Recommendations for UDI Systems
01 Apr 2013
News Europe's Proposed Medical Device Regulation
01 Mar 2013
News eIFU from 1st March 2-13 - European Commission Regulation (EU) No 207/2012
01 Feb 2013
News Scientific Disagreements Regarding Medical Device Regulatory Decisions
01 Jun 2012
News Factors to consider when making benefit-risks determinations in Medical Device Pre-market approval and De Novo classifications
01 Mar 2012
News New Borderline & Classification Medical Device document
09 Apr 2012
News MEDDEV 2.1/3 Rev3
08 Apr 2012
News MEDDEV 2.12-1 Rev6
07 Apr 2012
News Medical Device Directive
06 Apr 2012
News Medical Device Directive
05 Apr 2012
News Medical Device Directive
05 Apr 2012
MEDDEV 2.12-1 Rev6 07 Apr 2012

Medical Devices Guidance Document; Vigilance System

These guidelines on the Medical Device Vigilance System are part of a set of Medical Device Guidelines that promote a common approach by manufacturers and
Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the directives, and by the National Competent Authorities charged with safeguarding public health.

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