July 24, 2018

Imported Medical Devices Account for 93 % of Total Recalls in Shanghai

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 first half of 2018, including […]
July 18, 2018

AI Industry Pushing Forward, Mandated by China State Council

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 imaging diagnostics for eyes, lungs […]
July 17, 2018
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Webinar on CFDA Oversea Inspection– It’s time to take it seriously!

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 legal requirements? Join us for […]
July 17, 2018

CFDA Q&A: Clinical Trial Quality Management for Medical Devices

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 16, 2018

Two Invoice Policy Will Reshape China Distribution Landscape (2)

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” has been implemented in 24 […]