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2026 China NMPA Bluebook is here:
The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research
The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary
The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and
The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval: YY/T 0273-2022 Dentistry-Dental amalgam
The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed to
The NMPA granted Innovation Approvals to Medtronic and three others in May 2022: Medtronic: Transcatheter Implantable Leadless Pacing System Beijing Hengsheng: Disposable Intravascular Imaging Catheter
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China
The NMPA finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, just two weeks after the draft version. The plan includes
The NMPA issued the “2022 Medical Device Industry Standards Revisions Plan” today, April 14, 2022, for public opinions. Comments need to be submitted by April
Here’s the latest China regulatory and clinical affairs China NMPA News March 2022 for medical device and IVDs pros. These updates are presented by China
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and aesthetic devices and modified intended use for some with an announcement on March 24, 2022. NMPA
According to the “Administrative Measures for Registration and Filing of Medical Devices” and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, the