What is the role of customs in controlling the import and export of IVDs?

Apr 11, 2025 ... Any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate or diagnose disease in man. In vitro diagnostic medical devices (IVDs) according to IVDR2 that are placed on the market in Switzerland and/or in Liechtenstein for the first time by ... The main importing Medical Device is diagnostic Imaging Medical Device. (about 31.5% of total Thai Medical Device market) The major country of this. 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. On the other hand, an IVD refers to a medical device, whether utilized independently or in conjunction, designed by the manufacturer to examine specimens ... The documents below detail the requirements that UNICEF applies to medical devices, in vitro diagnostics devices and personal protective equipment (PPE). The role will also include auditing to EU MDR (EU medical device regulation 2017/745), UK MDR 2002 for medical devices and IVDs, ISO 13485 and MDSAP, ... In Vitro Diagnostic medical devices (IVD). Reference, Title, Publication. MDCG ... medical devices for the information and instructions that accompany a device in ... Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices. Oct 7, 2016 ... An in vitro diagnostic device, or IVDD, means a medical device or a product subject to section 3 of the Medical Devices Regulations that is ...