CFDA Updates

March 9, 2018

Chunli Orthopedic got 2 innovation approvals from CFDA

China accelerates medical device innovation. In February 2018, 7 products got approved through fast track pathway. Among them are two from Chunli Orthopedic, based in Beijing. No foreign manufacturers are […]
March 6, 2018

Monthly CFDA News Roundup (Feb 2018)

Monthly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing […]
March 5, 2018

China Approves First Device through Marketing Authorization Holder Program, Green Lights Contract Manufacturing

China’s State Council announced a pilot program for medical device Marketing Authorization Holder (MAH) System at Shanghai free trade zone on Jan 5, 2018. On Feb 27, first approval through […]
March 5, 2018

Weekly CFDA News Roundup (Feb 25th to Mar 4th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing […]
March 1, 2018

New 3D Printed Medical Device Draft Guideline: Propels China to Leadership

New 3D printed medical device draft guideline will propel China to be the leader in innovation & market acceptance in orthopedic and dental applications.   CFDA issued “customize-designed additive manufactured […]