Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Major Growth Factors These 4 major growth factors are pushing China’s medical device industry into the world’s 2nd largest: As a sub-industry of the pharmaceutical
Understanding to the “Amendments to the Registration Management Measures of in Vitro Diagnostic Reagents” The reason of the amendments: The development of in vitro diagnostic
China med Device, LLC provides market access research for Western medical device companies. Recently MinSheng Pharma published an in-depth analysis on China CVD market. CVD
China Food and Drug Administration (CFDA) pays high attention to the innovation and development of medical device industry. In order to better implement the “Fast
CFDA Application Acceptance According to Insight-China Pharma Data, a total of 304 medical devices registration were accepted in June 2017 (counted by numbers of acceptance),
In this month, a Sino-US medical device clinical trial supervision exchange meeting was jointly held by the CFDA’s department of international cooperation, medical devices management
On July 19, the 37th Meeting of Comprehensively Deepening Reform Leading Group of the Central Committee of the Communist Party of China was held, which
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.
In order to ensure the implementation of “Registration of IVD Reagents Administrative Decree”, National Institute Food and Drug Control (NIFDC), a national testing center authorized
According to a 2016 report by US Government from its export data, the best selling medical devices in China are from these product categories: In
CFDA has issued 2 new guidelines from June 17rd to June 20th. Even though they are called guidelines, once they are released, you are expected