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.
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