IVD industry full scan

DETAILS

Concept and classification of in vitro diagnosis

Basic concepts: In-Vitro Diagnostics (IVD) refers to the use of in-vitro testing reagents, kits, calibrators, quality control substances and other samples from the human body to detect and verify samples for disease prevention, diagnosis, treatment testing, post-observation, health assessment, etc. The process of genetic disease prediction.

Classification: there are three main methods for in vitro diagnostic classification.

(1) According to the main functions, it can be divided into biochemistry, blood gas, microorganism, hemagglutination, blood cells, molecular diagnosis, urine and so on. There are also some in vitro diagnoses which contain many test items, such as blood collection, multi-item quality control products.

(2) According to the testing environment and conditions, in vitro diagnosis can be divided into clinical laboratory in vitro diagnosis and on-the-spot diagnosis (POCT), in which the former is mainly completed by professional personnel, time-consuming, but the quality of the test results is high, while the latter can be operated by non-professional personnel, detection speed is fast, mainly concentrated. In blood glucose testing, blood gas and lysate analysis, rapid hemagglutination testing, rapid diagnosis of heart markers, drug abuse screening, urine analysis, dry biochemical testing, pregnancy testing, fecal occult blood analysis, food pathogen screening, hemoglobin testing, infectious disease testing, triglycerides and cholesterol and other blood lipids. The 13 item.

(3) According to the principle and method of detection, the most commonly used classification method is divided into four categories: biochemical reagents, immunological diagnosis, molecular diagnosis, and immediate detection (POCT).

In vitro diagnostic monitoring system

In vitro diagnosis includes two inseparable parts: diagnostic instruments and diagnostic reagents. Among them, the diagnostic instruments follow the management system of medical devices, and the relevant reference can be made to the Regulations on the Supervision and Administration of Medical Devices (Order 650 of the State Council). The Administration Department of in vitro diagnostic reagents in China is the State Food and Drug Administration, and the Department of Medical Devices Supervision is responsible for the administration. Appropriate permission is required from the start-up to product registration, production and operation.

Diagnostic reagent registration, production, operation process and related laws and regulations

The management of diagnostic reagents in China has gone through three stages:

Since 2001, China's in vitro diagnostic reagent regulatory system has undergone several adjustments. At present, most diagnostic reagents are clearly used as medical device management, and the product registration management is divided into three categories according to the level of risk.

China's in vitro diagnostic reagent industry is developing rapidly, and the relevant systems and regulations are constantly being discussed and revised and improved, so as to meet the needs of the constantly updated medical device industry and the requirements of clinical use and supervision.