What is the role of the National Medical Products Administration (NMPA) in IVD regulation in China?

Dec 6, 2024 ... IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). May 16, 2012 ... Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device'. Study Group 1 Final Document GHTF/SG1/N071:2012. May ... May 27, 2022 ... The EU's new In Vitro Diagnostic Medical Device Regulation (IVDR) "will have a tremendous impact on the MedTech industry". Read more here. Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) ... Sep 26, 2012 ... The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European ... Jan 30, 2025 ... Apply for this Permanent full-time, IVD Medical Device Lead Auditor job in Oldbury on Reed.co.uk, the UK's #1 job site. “Modified Device” is a medical device(or an IVD) that is equivalent in 'Intended Use', 'Mechanism of Action(MoA)', 'Raw Materials(Limited to implanted/contacted ... Jul 10, 2014 ... IVDs are categorised as medical devices under the Medicines Act 1981 and suppliers of IVDs are expected to notify Medsafe of any safety issue or ... (b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device--the relevant Level 2 collective term; and. (c) for a Class 3 ... Veristat offers a team of scientific-minded regulatory experts who understand how to develop the documentation and elaboration needed to support the CE mark ...