CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?
With the upcoming Sponsor Information Day being held in Canberra, there will be a great opportunity to network with others from the industry, and most importantly get face to face with our Regulatory Authority. In the past, it was certainly the impression amongst the industry that our agency was not as transparent or as approachable as […]
In mid-July, TGA updated the Standard Conditions of ARTG registration and hard wire them into the regulations. They are no longer needed to be included on each certificate and will be much more consistently applied – and policed. Standard conditions matter. This may seem like boring regulatory small print, but standard conditions set up real world obligations which if not met provide straightforward grounds for regulatory action. At a minimum, breach of any of these conditions constitutes grounds for cancellation of a product registration. In serious cases criminal or civil penalties may apply.
Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. The window for applications closes on 22 July
China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
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.