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
In the wave of global trade, countries have established various product certification standards to protect the rights of their consumers and maintain market order. For companies looking to enter the Gulf Cooperation Council (GCC) member states market, GCC certification is an indispensable “key”. This article will provide a detailed introduction to the steps and related … Read more
1. What is the Normal Operating Range (NOR), and how should it be presented in marketing authorization application documents? Answer: NOR is not a defined ICH term.NOR describes a region around the target operating conditions that encompasses normal operational variability (i.e., variability that cannot always be controlled). Multiple process parameters of the same process step … Read more
Author: Zhao Xiaofei IoT Think Tank Original Please indicate the source and origin when reprinting Introduction Yesterday, the official website and WeChat account of the Ministry of Industry and Information Technology (MIIT) publicly released the “Announcement on Low-Power Short-Distance Radio Transmission Equipment” (Announcement No. 52 of 2019). After nearly two years since December 2017, the … Read more