The foundation of medical device compliance is the Technical File – the data package which contains all of the information on the design and manufacture of your device and which supports its safety and performance. This month, Senior Consultant Jean Boudaud looks at what’s in a Technical File, how it relates to the DHF and DMR and how to build one file that will work for Europe, USA and just about anywhere.
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A year on since the Sansom review, TGA is hard at work implementing recommendations to streamline assessments and leverage international reviews. At the same time reform of reimbursement continues. We look at the progress so far, plans for Australian 3rd party assessors and ask – what would to take for TGA to recognise an FDA approval and how do I get paid in the land of Oz?
To the outsider, the Japanese regulatory process may seem obscure. But with the internationally harmonised Japanese Pharmaceutical and Medical Devices Law now fully implemented, things aren’t so complex as you may think. Register now and join our guest speaker, Hajime Kawasaki-san from our Japan office. Kawasaki-san will take a look at how things work in […]
Multiple policy consultations announced over the past 2 months point to China dialing down the number of devices (including 130 new exempted IVDs) requiring clinical trials and gingerly stepping towards a return to acceptance of foreign clinical data. At the same time CFDA continues to beef up postmarket surveillance and auditing. We take a look […]
In May 2017 the European Union published the final Medical Device and IVD Regulations kicking off a 3 year transition period (5 years for IVDs) for implementation of a much more rigorous regulatory regime for medical technology. We take a look at what’s changed – and just as importantly, what’s staying the same (hint – the underlying regulatory processes are the same, what’s changed is in some devilish detail and a much more centralised and strict supervision of assessors). We also take a look at the lessons learned from implementation of an almost identical IVD regulatory regime in Australia – which in a strange coincidence ended its transition just as the European started theirs.
It’s almost 2 years since CFDA’s Order 650 re-wrote the book on Chinese regulations and the pace of change keeps on going. These past few months have seen abolition of Type Testing Fees (not necessarily good news), updates to the priority and expedited pathways and more. Arthur Brandwood and Beijing based Senior Consultant Jeff Sun discuss the latest news from CFDA.
The Taiwanese market continues to grow and things are settling down after major regulatory reforms in Taiwan. Listen to Rachel Tserng, Senior Consultant- Regulatory Affairs to hear how to tackle the unique regulatory requirements for the Taiwan FDA.
There’s so much change going on, with the upgrade to ISO 13485:2016 and the transition to the new European regulations. What is notable, is how much of the change is now focused on postmarket – i.e. requirements to ensure continuing compliance and safety once the product is approved for marketing. For sure there are updates to document requirements for conformity assessment, but the biggest changes in both ISO 13485 and the EC Regulation are all about active vigilance.
With changes announced to some prostheses prices, a Senate inquiry and continuing reform of private health insurance, 2017 is set to be an eventful year for suppliers of medical technology to the Australian market. Australia continues to be an excellent market for medical technology but it has a complex and changing landscape for suppliers. Join Sarah Griffin, Principle Reimbursement Consultant as she analyses the current situation and looks at the likely scenarios for the future.
Biological safety evaluation has always been a thorny aspect of device development and regulatory review. For too long, the approach has been to spend up big on lots of laboratory testing and tick the boxes against the ISO 10993 guidance. However expectations are changing rapidly. join Arthur Brandwood – Principal Consultant (and participant in ISO 10993 standards writing for over 20 years) to take a look at the evolving practices for regulatory review of biocompatibility.