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2025 China NMPA Bluebook is here:
3 CFDA national leaders and 7 provincial leaders have been demoted as a result of the recent vaccines poor quality incident for the oversight over the substandard vaccines manufactured by
In 2017, NMPA (CFDA) announced the first batch of approved combination products in China In 2017, NMPA (CFDA) announced the first batch of approved combination products since the release of
In 2017, CFDA announced the first batch of approved combination products in China In 2017, CFDA announced the first batch of approved combination products since the release of the combination
Monthly 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),
The China State Council issued tariff plan worth $60 billion on the 2nd batch of goods imported from U.S. on August 3. It will impose duties of 25%, 20%, 10%
CFDA Medical Device Classification Catalog draft was published August 31, 2017. A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the
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
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)
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
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
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
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