The NMPA granted Innovation Approvals to two overseas manufacturers in August 2022: Ethicon: Oxidized Regenerated Cellulose (ORC) powder BioFire Diagnostics: Meningitis/Encephalitis (ME) detection panel What are the Devices The NMPA
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical and clinical requirements are outlined below.
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 Beijing Hengsheng: Intravascular Imaging Equipment
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 23 mandatory and 93 recommended