Regulatory colleagues working with CFDA will be familiar with the “Open Window Thursdays” – where the Center for Medical Device Evaluation accepted visits from all comers to ask questions about upcoming device applications. it was sometimes chaotic and unpredictable, but a strangely pragmatic and informal way to do rapid consultations with the review divisions prior to filing a submission.
This all stopped when CMDE ended all pre-consultations a couple of months back and closed the window.
Well the good news is that it’s back. CMDE have announced they are restarting consultation sessions, on Fridays between 1 and 4 PM, no appointment required (but get there early – expect a queue!).
Click here to download a copy of the CMDE announcement (English and Mandarin).
Here’s to “Open Window Friday”!
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