The long awaited output of the Bangkok meeting of AHWP has finally been published on the AHWP website. There’s a new white paper on combination products as well as guidance on software, STED format, clinical evaluation (both devices and IVDs) and more.
Archives for January 2016
Most IVDs have been more lightly regulated than other medical devices – especially in Europe and US. But in the East, much more stringent regulation is the norm. But with Europe introducing new regulations and stricter classifications, and FDA talking tough on LDTs – will 2016 be the crunch year when the west follows east and gets tougher on IVDs?
The pace of change doesn’t slow down… the past year saw sweeping reforms in China, reorganisation of the Korean agency and new administrative processes in that market, introduction of the new Medical Devices Law in Japan and the promulgation of the ASEAN Medical Device Directive and recommendations for substantial reforms in Australia. 2016 doesn’t look like slowing down. Join us for a FREE webinar update on Asia Pacific regulations.
Rapid growth in our global practice has created opportunities for new consulting staff in our Sydney and Beijing offices. Interested in joining a top flight team with exposure to a wide range of regulatory practice and substantial opportunities for international experience? Email General Manager Grant Bennett at Grant@brandwoodbiomedical.com to arrange a confidential chat.
Each December Australia’s TGA reports statistics on its premarket and postmarket activities. So how long does it take for TGA to review a submission and what’s likely to happen if you have a postmarket event? We take a look at the latest numbers.
FDA’s latest reviewer experiential learning program identifies new priorities for training. Hot button items are biocompatibility, clinical trials and emerging manufacturing technologies