CRO Updates

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 […]
September 7, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 2 Biological Testing

Biological testing points Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be cleared in advance. 2. Identify biological […]
September 4, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 1 Performance Testing

China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The […]
August 17, 2018

Problems and Suggestions for Medical Device Clinical Auditing in China

In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions.   Clinical […]
July 17, 2018

CFDA Q&A: Clinical Trial Quality Management for Medical Devices

Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution? A: For the multi-center clinical trials, the one-year validity period is calculated […]