Regulators the World over have been toughening up on the requirements for clinical evidence of safety and performance of medical devices. More devices are required to have direct clinical trial data, and where literature based evidence is accepted, the standards are getting tougher. China’s CFDA strengthened clinical evidence requirements as it revamped regulations over the past two years and Australia’s TGA currently has a new Clinical Evidence guidance out for consultation. We take a look, the international similarities are striking.
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.
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.
Regulators around the world are ramping up expectations for clinical evaluation of medical devices – all devices – with tougher requirements for higher risk devices and especially implantables. So what’s involved in collecting the evidence and preparing a Clinical Evaluation Report?