It is difficult to not marvel at Chinese efficiency when you look at the speed of China bringing about its medical device regulatory reform. From the 1 June 2014, the newly revised Regulation for the Supervision and Management of Medical Devices comes into force, with it, the Provision for Class I Device Filing. The later of this was announced merely 3 days prior to implementation, and practically rejected all Class I registration in progress, mandating them to reapply under the new Provision. One would hope the same would be applied to Provision for Medical Device/IVD Reagent Registration which governs Class II and III devices as well.
Our webinar will help you equip yourself with the frontier of regulatory changes in China!