Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to
Shanghai CFDA office released Medical Device Half Year Recall Report on July 20. Total 165 medical devices have been voluntarily recalled in Shanghai for the
China State Council published an article on AI medical device on July 9th, aiming to propel China to the leadership of AI devices, especially AI-infused
Are you ready for CFDA’s oversea inspection? Do you comply with Chinese Medical Device Good Manufacturing Practice? Does your current quality system meet the Chinese
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
Two Invoice Policy in China Brings Great Opportunities for The Integration of Medical Device Industry At the end of January 2018, the “Two Invoice Policy”
“Two Invoice Policy” means that the pharmaceutical production enterprise issues one invoice to the circulation enterprise, and the circulation enterprise issues one invoice to the
Monthly Opinions on Device Registration covers preclinical, clinical and registration issues in medical device and IVD in China. It is published by CFDA and edited
CFDA granted innovation approval status for 28 medical devices in the first half of the year, covering the indication of cardiovascular (10), oncology (7), orthopedic
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
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
Thanks to advantages such as high precision, solidity of finished products, and the ability to copy complex geometric models, 3D printing technology is increasingly used