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
CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.
The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
The technical review guideline on HCV Genotyping Testing Reagent for comments.
The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System