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Monthly NMPA (CFDA) News Roundup (August) Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and
Monthly CFDA News Roundup (August) Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in
Biological testing points 1. Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be
China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified
NMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31st. More
From 2009 to the present, a total of 138 products have been applied for classification, and nearly one-third of the products were applied in 2017
CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is
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
Weekly CFDA News Roundup covers government reports, policies, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China