Meeting with EC DG Trade preparing for the ETWG meeting

2015-05-05 | Beijing, Shanghai

Medical Device industry raised issues related to the regulations for the supervision and administration of medical devices. Including 1) asking CFDA to put in place a robust system that allows swift updates of the clinical trial exemption catalogues for Class II&III medical devices 2) consider to accept clinical data outside China 3) on Registration fee, recommend CFDA and other correponding authorities to charge inspections based on actual costs, and recommend CFDA adopt specific and measurable goals to demonstarte progress 4) asking the Chinese authorities specify the definition of “domestic-made products” and conduct assessment based on the R&D features of medical devices to turn a made-in-China product with a global brand into a domestic-made product and enable JVs and WOFEs to gain equal treatment in China 5) accept Electromagnetic Compatibility (EMC) testing report outside China 6) transitional period for new regulations