A new draft version of the Guidance on IVD reagent clinical trial has been published for public comment. It establishes sample requirement for immunoassays and sets new clinical trial requirement for product variation. CFDA will accept written feedback to the draft Guidance until 31 August 2014.
Archives for August 2014
In response to the BMJ article exposing eight Notified Bodies as “likely to be more interested in repeat business than patient safety”, TGA has acted to mandate document audits of all applications based on CE certification from these bodies.
Biocompatibility is high on the Agenda when China’s biggest regulatory forum CIMDR convenes in Xiamen in two weeks time. The special sub-forum on biological evaluation on Friday 29th August will bring together four of the experts from ISO TC 194 (the group that writes the 10993 standards), along with two senior officials responsible for biological evaluation reviews in China.
CFDA essentially has allowed all issued registration certificate to run its course without any mandate for immediate updates; applications accepted for review before 1 Oct 2014 will be processed under the old pathways, while as applications accepted after 1 Oct 2014 must be prepared according to the new Provisions.