EN 60601-1:2006/A1: 2013 introduces 496 technical and editorial amendments to the standard. There’s a short December 2016 transition deadline for the Annex ZZ cross reference to the Directives. Start reading now
Archives for May 2014
The technical arm of the CFDA has announced the first successful applicant going through the Innovative Device Pathway. The lucky first is an absorbable dural sealant developed by a domestic manufacturer.
Korea has announced revision to its top tier medical device regulation – the Medical Device Act. A new revision to the Act will be effective as of 29 July 2014. The key change is mandating a Quality Management Representative to be appointed for manufacturers/importers of Class I devices. This is aimed at boosting quality control […]
Simplification and harmonization have been two keywords prompting medical device regulatory reform in Asia. As an active member of the AHWP (Asian Harmonization Working Party), Taiwan has been implementing step-by-step changes in bringing its medical device regulation more in line with the GHTF framework.
The second round of consultation is underway for the proposed provisions on medical device and in vitro diagnostics registration and filing. Now is your chance to voice your thoughts on what should be included or excluded from the Chinese requirements.
ISO Technical Committee 194 met in Mishima, Japan in late April – to work on the latest updates to the ISO 10993 biocompatibility standards as well as ISO 14155 on devices clinical trials. There was the usual substantial work on technical revisions to the 10993 series. However the most significant work carried out in Mishima will have a longer term impact with the foundations being laid for phase out of animal testing for sensitization and irritation and for much greater use of risk management approaches to biocompatiblity.