NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical […]
NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” on December 13, 2019. Feedbacks need to be submitted by January 13, 2020. Eight […]
Only one out of five medical devices granted Innovative Device Status by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and […]
“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on the NMPA filed institutions for […]
You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory […]
Pic: China Premier Li Keqiang visited the Hainan International Medical Tourism Pilot Zone on Mar 25, 2019. NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]