Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual benefits and challenges this Pathway brings. In this article, I try to make it a little clearer on what leads to a successful application and […]
Even though the February 2018 Prostheses List has yet to come into effect, the deadlines for submitting applications to the August List are fast approaching. Missing a deadline can delay your access to the private hospital market by at least 6 months. The deadline for Ophthalmic, Urogenital, Specialist Orthopaedic, Cardiac, Cardiothoracic, Vascular, Hip, Knee and […]
There is likely to be a lot of activity in the Private Health Sector in Australia in 2018, particularly in medical devices. Following on from the highly publicised five-year Prostheses agreement between the Commonwealth Department of Health and the Medical Technology Association of Australia, implementation of the agreement must now take place. The agreement included […]
We are delighted to confirm that the forthcoming Asia Pacific Device Summit will feature a presentation by Yongheng Chang of China Food and Drug Administration. Mr Chang will speak on China’s Policies to support Medical Device Innovation including navigating the Innovative Device Pathway for CFDA approval, He will also provide an up to the minute […]
The new European MDR and IVDR require that all devices are re-qualified – no grandfathering here. So how much clinical data is enough for established devices? European guidance is in the works. It’s time to speak to your Notified Body.
As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the requirements for the new Priority review designations For Medical devices (including IVDs). The TGA had discussed the availability of this process as a result of […]