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.
- Noticeon “On-site Consultation on technical issues before medical devices registration”
- Noticeon “Enabled CFDA Administration Acceptance Service Hall Online Reservation System
1. On July 4th,CFDA issues a noticeon “On-site Consultation on technical issues before medical devices registration”.
From July 7th, 2017, the administrative service hall starts to implement on-site Consultation on technical issues before products’ registration. CMDE of CFDA and the staff in the six review & evaluation departments will provide the specific consultation. The consultationtimeis from 1:00 pm to 4:00 pm every Friday.
|2017.07.07||General service division|
|2017.07.14||Review department 1|
|2017.07.21||Review department 2|
|2017.07.28||Review department 3|
|2017.08.04||Review department 4|
|2017.08.11||Review department 5|
|2017.08.18||Review department 6|
|2017.08.25||General service division|
2. On July 13h,CFDA issues a noticeon “Enabled CFDA Administration Service Hall Online Reservation System”
- Reservation Scope: Accept safety supervision and other administrative licensing matters, on-site consultation and receiving approval documentsfor drugs, medical device, special foods and cosmetics.
- Online Time: Begin at September 1st, 2017
- Registration Methods: http://www.cfda.gov.cn/WS01/CL0025/ for online registration. Applicants could start appointment service after getting the registration approval.
- Appointment Methods: http://www.cfda.gov.cn/WS01/CL0025/ for making an appointment. One registered company could add 10 service staffs. One service type could make one appointment in one business day.
- Break Appointment limit: Applicant could cancel the appointment 4 days before the appointed time. CFDA will freeze the company registration account for 30 days if the company breaks the appointment for 3 times.
- Appointment Priority: CFDA encourage applicants to make appointments online.
About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services.
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