December 11, 2019

16 Devices Recalled in November; One Class I Recall

NMPA announced Recall Notices for 16 imported medical devices in November. Class I recall (the most serious): Edwards Lifesciences: Aortic perfusion cannula Class II and Class III recall: GE: Patient […]
December 9, 2019

Grace Palma, CEO of China Med Device, to Talk on Precision Medicine Panel of CABA Meeting

Grace Palma, CEO of China Med Device, is invited to talk on Precision Medicine Panel of CABA (Chinese-American BioMedical Association) meeting in Boston. Grace will focus on IVD/CDx regulatory and clinical […]
December 6, 2019

Record number of Guidelines and Standards announced by NMPA in November

NMPA published unprecedented number of medical device regulations in November, including 21 final guidelines, 14 draft guidelines for feedback and 19 final industry standards. Generic Guidelines Among those are three […]
December 5, 2019
Medical Device GMP in China

GMP for Medical Devices in China – A Quick Guide

Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical […]
November 26, 2019

NMPA New Guideline on How to Address “Submission Deficiency” in China

NMPA issued the “Medical Device Submission Document Requirements during the Supplement Phase” (Draft) on November 11, 2019. Feedback needs to be summited by November 30, 2019. The document specifies the […]