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.
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?
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?