Although the Europeans have retained risk classifications and 3rd party conformity assessment based on risk class, the new MDR changes almost everything. In more than ten times as many words as the MDD and AIMD, the new regulations provide much more detailed requirements and set a higher bar especially in clinical evidence, postmarket monitoring and risk management, integrating all of these into a single living process. The race is on for the three year transition period – it’s going to get busy…
Last week, the Australian Therapeutic Goods Administration (TGA) published the final guidelines on Clinical Evidence for devices. The guidelines reiterate key elements of clinical evaluation that are often missing from Clinical Evidence Reports. The guidelines also provide specific requirements for certain high risk devices.
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.
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.