1. Project Overview The project is located in the Lucheng Industrial Zone of Huangcun Town, Daxing District, Beijing (east to Xinhang Street, west to Planning Road, south to Efang South Road, and north to Chuangye Road). The total land area of the site is 7,054.33 square meters, and the total construction area of the project … Read more
01 / Question/ Can changes for new standards be combined with renewal registration for in vitro diagnostic instruments? 02 / Answer/ No. If the implementation of new standards involves substantial revisions to the technical requirements of the product, a separate change registration must be processed. WeChat Official Account Mass Spectrometry Medical Devices END Disclaimer: The … Read more
Welcome to follow China In Vitro Diagnostic Network CAIVD (1) Overview of Biochemical Diagnostic Instruments The biochemical analyzer, also known as the biochemical instrument, is an instrument that uses photometric principles and biochemical analysis methods to measure specific chemical components in bodily fluids. Due to its fast measurement speed, high accuracy, and low reagent consumption, … Read more
01 In Vitro Diagnostic Industry Chain Overview The upstream of in vitro diagnostics mainly includes R&D and production of raw materials, reagents, and core components required for in vitro diagnostics., reagents include antigens, antibodies, biological enzymes, and magnetic microspheres, while core components include single-photon counting modules, lasers, sensors, plunger pumps, and sheath flow cells. The … Read more
In the field of in vitro diagnostics, the reagent instructions serve as a “guideline for action” that directs users on proper operation to ensure accurate and reliable test results. Among these, the description of instrument parameter configuration is a critical aspect. Today, we will delve into how to describe instrument parameter configuration in the instructions … Read more
In Vitro Diagnostic Instruments In vitro diagnostic instruments refer to devices that obtain relevant clinical diagnostic information by testing human samples (such as blood, body fluids, tissues, etc.) outside the human body, helping to assess diseases or bodily functions. 1. Biochemical Analyzers Image source from the internet, please contact for removal if there is infringement. … Read more
Source: Longma Capital Research Team Author: Min Yue POCT (Point-of-Care Testing) is a sub-sector of the in vitro diagnostics industry, referring to rapid diagnostics performed at the patient’s side. It involves immediate analysis at the sampling site, eliminating the complex processing procedures required during laboratory testing, thus providing a new method for quickly obtaining test … Read more
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