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Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing
NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-test and to submit the
NMPA issued the 2021 Medical Device Industry Standards Revisions Plan (draft) on May 26, in which 77 medical devices and IVDs are affected. The Standards
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in May 2021. Policies Major
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019. Medical device master file in
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On
The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device
By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in