July

July 31, 2018

Overseas Inspection: There are Defects CFDA Chasing

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 publish overseas inspection results, 24 […]
July 25, 2018

Weekly CFDA News Roundup (July 16th to July 22nd)

Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]
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 […]