China’s 13th National People’s Congress approved a merger of a host of current regulatory agencies – including CFDA, into a new super-ministry for all things regulatory. We take a look at the powers of the new SMRA – or the State Market Regulatory Administration and ask what it means for CFDA’s devices reforms.
At the March 2018 Shanghai meeting of IMDRF, new work item proposals from China on GCP practices and the update of technical standards were approved. These seemingly routine administrative efforts mask a radical change – with China for the first time taking the lead on IMDRF harmonization efforts and seeking to promulgate its own approaches into global regulation. We take a look at what’s really going on.
TGA is proceeding to update its Advertising regulations. The next step is a public consultation ending 27 April 2018. We look at the specific changes and their impact.
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 […]