Apr 26, 2017

UL übernimmt Emergo

Emergo wurde von UL (Underwriters Laboratories) akquiriert und wird sein Beratungsangebot zur Qualitätssicherung und zu...
May 20, 2011

Code of Conduct for Notified Bodies Goes Public

Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA have made public a code...
May 16, 2011

Recast of EU’s Hazardous Material Regulations to Impact Medical Devices

The European Union’s Restriction on Hazardous Substances (RoHS) Directive covering electronic devices will soon also...
Feb 28, 2011

Evolving IVD Regulations in Europe

In Europe, a response was published to public comments on the proposed recast of Directive 98/79/EC.
Feb 28, 2011

Australia TGA Clarification on IVD Audits

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations,...
Feb 25, 2011

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
Feb 16, 2011

Certain IVDs Now Subject to Application Audits by Australia’s TGA

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo
Dec 2, 2010

Australian TGA Updates IVD Regulations

The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010...
Dec 2, 2010

Important regulatory changes in Australia

IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on ...
Dec 2, 2010

Changes to TGA Medical Device Applications & IVD Guidance Documents

There are modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.

Pages