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2026 China NMPA Bluebook is here:
CFDA announced Unique Device Identification (UDI) draft plan for feedback on August 22, to adequately identify medical devices through their distribution and use. When fully
On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables. 1. Test methods for packaging
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
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
3 NMPA (CFDA) national leaders and 7 provincial leaders have been demoted as a result of the recent vaccines poor quality incident for the oversight
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
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
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
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
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
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
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