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CFDA Release Recently, CFDA released 8 medical device industry standards and a modification including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General requirements”
CFDA UPDATE CFDA Update: CFDA has approved iCAD Inc.’s Xoft Axxent balloon applicators for the treatment of early-stage breast cancer. This approval makes the complete
Tekni-Plex Facility This brand-new factory in Suzhou, China belonging to Tekni-Plex, a US-based packaging company, recently opened it door for business. It is now producing
CFDA recently issued the No. 99 Announcement of 2017, which issued YY / T 1574-2017 “The guide of the alginate gel fixation or microencapsulation of the tissue
On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory
China Med Device, LLC Founder and CEO, Grace Fu Palma, will be speaking on CFDA approval and updates at the upcoming 2017 RAPS Regulatory Convergence
The 8th China International Medical Device Regulatory Forum was held in Hangzhou in August. Xiao Hong, deputy director general of China Food and Drug Administration，
On August 8th, CFDA issued a drafted notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on
A Shanghai JV Is Created To Invest In International Medical Device Companies The Trendlines Group is an Israeli medical technology incubator that focuses on developing
To enter the Chinese market, partnership forged between international medical device manufacturers and local Chinese firms is on the rise. In such partnership, the medical
The Review and Approval of Innovative Medical Devices In 2016, China Food and Drug Administration received a total of 197 applications for approval of innovative
1. The Review and Approval of Medical Device Registration Applications In 2016, China Food and Drug Administration completed a total of 9336 technical reviews of