October 12, 2020 — Hainan Province, China. This real-world data study of China clinical evaluation in the Hainan pilot zone will help urgent need medical devices. For example, it allows […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]