clinical trial

January 11, 2019

NMPA (CFDA) Must Read: Acceptance of Overseas Clinical Data

NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical […]
December 14, 2018

9 Clinical Trials Have Compliance Issues in NMPA Inspection

In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results […]
November 30, 2018

More IVD Clinical Trials to Receive NMPA (CFDA) Clinical Audit

The compliance with the NMPA (CFDA) clinical trial requirements in China is getting more strictly audited and reinforced.  On November 13th, NMPA (CFDA) issued the 2nd notification in 2018 for […]
November 26, 2018

NMPA (CFDA) New IVD Clinical Guideline: 11 Requirements You Should be Prepared for!

NMPA (CFDA) published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018 during the U.S. Thanksgiving holiday. After initial clinical guideline issued in September 2014, NMPA (CFDA) has […]
October 14, 2018

Siemens, Medtronic Found Incompliance in CFDA Clinical Audit

For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report.  In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with […]