I will be submitting a standalone software device soon to NMPA. It is a major revision to the product previously registered with CFDA and will hopefully require only an Amendment to License. What is the typical turnaround time for med device submissions with NMPA over the last couple of years? I have one that's been in queue for 6 months with no response and am making a plan for the next product release. I've heard between 16 and 24 months is common.