There is a Chinese saying “the one who tastes the crab first must be a brave person” – presumably because the fierce looking crustacean does not give any hint of its gastronomic potential. Nowadays, “crab eater” is used to refer to the first person to tread a path unknown – such as the absorbable stent system manufactured by Abbott Vascular which had recently been announced as the first non-Chinese manufacturer going through the new Innovative Device pathway which was introduced in March 2014.
There are now 23 successful candidates undergoing innovative device review. The pathway promises an expedited review process, but more importantly, a much deeper engagement and dialogue with CFDA to ensure that the technical challenges in assessment of new technologies are more easily managed.
Considering the Innovative device pathway in China? Please contact us for a free consultation.