Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.
India continues toward implementation of the new Medical Device Regulations with publication of a new classification catalogue for 250 devices and IVDs.
China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
After identifying that their current classification catalogue contained a number of deficiencies, the CFDA have release a draft document to update the catalogue first issued in 2002. The update is significant, and a move to categorise devices by functionality and clinical application is likely to improve the practical application of this classification catalogue and serve to update their regulations to better reflect the current state of the medical device market.
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
Classification rules are a great advantage in that any new device can be classified immediately: no need to consult lists of regulations here. But the rules take some effort to interpret and apply.
Enter “Classify My Device” a handy smartphone App which puts device classification in the palm of your hand…