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2026 China NMPA Bluebook is here:
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
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
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
B. The Acceptance Of Medical Device Registration Application In 2016, China Food and Drug Administration received a total of 8920 applications for medical device registration,
1. The Work on Medical Device Registration (a) The gradual improvement of medical device registration management regulatory system The issue of the ” Quality Management
2 new guidelines have been released by CFDA on August 9th. Even though they are called guidelines, once they are released, you are expected to comply with them
More Coordinated Efforts Between US FDA and China’s CFDA On ICH On August 9, 2017, in an FDAVoice blog post, Theresa M. Mullin, director of
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