A few days ago, people visited the CMDE (Center for Medical Device Evaluation) as usual to consult saw a notice, which says:
“With effect from today, the public consultation session every Thursday for the industry is closed, and online consulting to be officially open to the public in accordance to the Management Specification on Medical Device Technology Evaluation and Consultation. Subscribe now our wechat public account and send “Online Appointment” to us to get specifications on how to make an appointment online with CMDE and tips on it.”
And there are early birds who already put it into action, such as the second department of Evaluation.
“In accordance to the Management Specification on Medical Device Technology Evaluation and Consultation we released on October 20, 2016, and its trial announcement, from this week, we no longer receive consultation without reservation. Thank you for your cooperation.”
When a door was closed, another will open. February 7, 2017, China Food and Drug Administration (CFDA) released the notification of Administrative Measures for Evaluation, Communication, and Circulation of Medical Device (trial), which encourages medical device innovation, and guarantees the supply of medical device, and reinforces the communication between applicant and the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE.CFDA). Following is the analysis of this administration for your reference.
On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration released the Management Specification on Medical Device Technology Evaluation and Consultation. But in order to have a smooth transition, this Management Specification and the original public consulting Thursday occurred simultaneously for the first three months. And now, as this transition period is over, online appointment is the only option now.
