CFDA has restricted industry from dropping in or visiting its premarket submission review staff in the 6 departments (medical devices and IVDs) prior to registration or submission of the dossier. Industry can certainly understand the limited resources that CFDA has. FDA has the equivalent of 700 staff with a fewer submissions. CFDA has about 100 staff with more submissions. With so many changes in its updates and regulations, industry certainly needs clarity and onsite consultation prior to registration or submission. The current scheduled onsite consultation by each of the 6 departments certainly is a good step forward to address medtech industry's challenges. Medtech industry in China certainly hopes to see the day when companies can interact with CFDA review staff more openly and freely.
In addition to the onsite visit, CFDA also released online reservation system for companies to make appointments with the reviewers.
Notice on "On-site Consultation on technical issues before medical devices registration"
Notice on "Enabled CFDA Administration Acceptance Service Hall Online Reservation System
In 2017 the Two-Invoice System policy will evolve from last year’s pilot to full implementation, large enterprises will descend the channel while small and medium-sized agents will be eliminated, some […]