September 2013 saw the launch of the much talked about GS1 “Recallnet” in Australia. This automates and adds much greater control over recall notifications. Recallnet augments but does not replace the TGA recall process – users need to remember that the TGA procedures still must be followed.
Archives for February 2014
The long expected revision on the Regulation on the Supervision and Administration of Medical Devices has finally passed the Chinese National Council as of 12 February 2014. This signals a new era in Chinese medical device regulation. Compared to the current version (published in 2000), the new Regulation is expected to have significant improvement in several areas.
Through 2013, we TGA required reclassification of implantable load bearing joint prostheses from Class IIb to Class III. To encourage early submission, TGA offered a fee free window for applications submitted by June 30, applications after that and before the final deadline of June 30 2014 would have to pay fees.
In the largest update for some time, the US FDA has updated its list of recognized standards. In addition to a broad update to recognise more recent revisions there’s a large number of standards recognised for the first time. This latest batch of changes includes the long anticipated completion of transition to IEC 60601-1 3rd Edition.
CFDA recently published a draft revision for Chinese medical device classification guidelines which includes some conservative approaches which will place certain wound dressing products into higher risk classes than in the rest of the world and could have surprising consequences in the area of biocompatibility.
The deadline for bringing medical devices under the control of the Restriction of Hazardous Substances Directive (RoHS) is July 22 2014. So what’s changing? And what exemptions still exist (there are quite a few).