PLAC has signalled its intent to consult in its review of the Prostheses listing criteria. This is an important opportunity for sponsors of non-implantable technologies to have a say. The type of consultation that will take place has not been announced as yet, however sponsors should be ready to file a submission when an announcement is made. It is clearly time for a change and this represents the best opportunity for long-overdue reform.
Archives for February 2017
TGA has recently released its five new Declaration of Conformity templates specifically for IVDs. In this article we outline which template should be used depending on the conformity assessment route taken and the classification of the IVD.
Over the past several months, we’ve been discussing at a high level, the upcoming changes for manufacturers considering the introduction of the Medical Device Regulations (MDR), along with the implementation of the ISO 13485:2016 and MDSAP. In this article, we’ll discuss more specifically section 8.2.2 Complaint Handling requirements under the 2016 revision of the standard which has a 3 year transition.
China CFDA is proposing to allow the Center for Drug Evaluation (CDE) and Center for Medical Device Evaluation (CMDE) to directly approve some submissions, without requirement for final review and approval by the CFDA. This will speed up approvals for some submissions from both local manufacturers and importers. It’s another step in streamlining the Chinese regulatory bureaucracy and lessening of centralised control.
Innovative Pathways for fast track approval of new technologies are continually in the news. These pathways attempt to serve industry development goals in the guise of meeting unmet clinical needs. Still it’s a laudable goal. But are these programmes effective? or safe?