CRO Updates

December 31, 2019

More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

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 […]
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 […]
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 1. 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 […]
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 […]