CRO Updates
January 23, 2020
Going through China’s medical device clinical trial phases can be painstaking in terms of the cost and time. While more and more clinical exemptions have been issued by China’s NMPA […]
December 31, 2019
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
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
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
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
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
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
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 […]
July 11, 2018
CFDA published Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Clinical Guideline on Soft Contact Lens on July 5th, to facilitate the applicants with clinical trial process on […]
July 2, 2018
On June 11, CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial in […]
July 2, 2018
The GCP requirements on medical devices have intensified. On June 25, CFDA issued the first notification in 2018 for the upcoming clinical inspections for 9 medical devices and an IVD. […]
May 30, 2018
Which is your clinical pathway in China, CER or Clinical Trials? How to get oversea clinical data accepted by China SDA? How can you use CFDA unapproved device in China […]