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
CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” and “Revised Version: First Three Batches of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical […]
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. […]