Скачать с ютуб Clinical Pathways - China Medical Device Registration в хорошем качестве

Clinical Pathways - China Medical Device Registration

Website: https://www.cisema.com/en/ The Clinical Evaluation Report (CER) is one of the cornerstones of the NMPA (National Medical Products Administration - formerly CFDA) registration of medical devices. Whether a clinical trial in China is required for the CER can be determined using various exclusion criteria. The NMPA has published multiple batches of clinical trial exemption lists, detailing which Class II and III medical devices and IVDs do not require clinical trials in China for registration; instead, a highly simplified CER suffices. On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents already on the list. More information: https://bit.ly/36eDZoJ Class I medical devices do not need to undergo a type test or clinical trial in China; for these, a simple clinical evaluation suffices. In instances where a product does not appear on the clinical trial exemption list, clinical data which were collected in a clinical trial performed outside of China can be used to create the CER if these meet Chinese requirements. This was introduced on 11 November 2018 (NMPA Notice No. 2018-13). If such data are not available, there is the option of finding a predicate device approved in China and use its clinical data. The predicate device has to have the same: Chinese "common name" Product structure and configurations Functions and working mechanics Intended use and contraindications However, obtaining the clinical data in a legal manner can pose a challenge. A clinical trial for the product is only unavoidable if these three approaches are fruitless. Currently, another alternative to the clinical trial in China is emerging, because on December 13, 2019 the NMPA released a draft for the use of real- world data for the creation of a CER, “The Technical Guidelines for the Application of Real-World Data in Clinical Evaluation of Medical Devices”. Real-world data refers to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial (RCT). Possible sources can include patient-generated data or data derived from electronic health records. Certain guidelines have yet to be released before real-world data will be accepted as another clinical pathway for device approval in China. More information: https://bit.ly/2Tk3uQk On 26.03.2020, the NMPA (National Medical Products Administration) approved the US firm Allergan’s glaucoma drainage tube, the first imported medical device registered with the support of real-world data, which was collected in Hainan’s International Medical Tourism Pilot Zone. More information: https://bit.ly/3bLKlx0