December 9, 2019
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
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
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 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 […]
November 22, 2019
NMPA published five guidelines for 3D printed devices from August to October 2019: Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue Registration Guideline on 3D Printed […]