01 / Question/ Can existing test reports be used to cover new model registration changes for in vitro diagnostic instruments? 02 / Answer/ Provided that the new model can be considered as part of the same registration unit, the company should assess the representativeness of the performance of the existing model. If there are differences … Read more
Click the above “CAIVD” to follow us In 2018, the National Medical Products Administration released the “Catalog of Medical Devices Exempt from Clinical Trials” (hereinafter referred to as the new “Exemption Catalog”). The new “Exemption Catalog” includes a total of 1248 medical devices exempt from clinical trials, divided into two parts: “Medical Device Products” and … Read more
Click the blue text Follow us 【Safe Medication】 Column An An and Hui Hui continue to popularize knowledge for everyone An An What are in vitro diagnostic medical devices? What standards do they have? This issue of safe medication, let’s popularize knowledge together! Hui Hui Standards for In Vitro Diagnostic Medical Devices Standards for Instruments … Read more