Second, what is IVD?
Third, what is the status of IVD in the whole medical device product category?
Fourth, what is the relationship and difference between POCT and IVD?
Everything you see in the hospital, except drugs and people, is basically medical equipment.
IVD is undergoing in vitro diagnosis. For example, you will understand it more easily. For example, if a patient goes to the hospital with a cold, the doctor says that your cold is bacterial or viral, and you need to have your blood tested. Then the patient will have a blood test to get the report. The doctor will know whether it is bacteria or virus after reading the report.
Outside the human body, things used to measure blood, urine and other samples are IVD products to help doctors see a doctor. This is the task and value of IVD products. The samples mentioned here, besides common blood and urine, actually include many other samples from outside the body. For example, if I want to test the intestines, I need to use stool samples, or if I have nervous system diseases, I need to use cerebrospinal fluid samples, and so on. ......
? NMPA, also known as National Medical Products Administration, was once called CFDA and FDA in the United States and CE in Europe. Recently, masks and epidemic prevention materials have been exported, and many manufacturers have to pass FDA and CE certification. Instruments are divided into equipment, consumables and reagents, and IVD products are incidental. For example, early pregnancy test paper is a combination of reagents and consumables, and everyone can buy it home for their own use.
The application scenarios of IVD products are mainly in hospitals, clinics, medical technology and teaching. However, there are still many scenes that need IVD products, such as traffic police checking drunk driving, home blood glucose meter detecting blood sugar, and Hong Kong Customs detecting passengers passing through customs. So we need an IVD product, which may not be able to meet the high-speed detection of the testing center and detect hundreds of items at a time. There are not many items that can be tested at one time. However, this product that can quickly produce results for these projects is a very popular product in IVD industry recently, called POCT, which is actually a scene product. The characteristic of this scenario is that it needs to give the results quickly and can be operated without professionals. IVD's products include POCT, which is a branch of IVD.
In the 1970s, around 1970, domestic reagent substitution led to the appearance of the boss of the Food and Drug Administration. At that time, the country introduced some advanced technologies and equipment from Europe and America, and we also introduced some technologies and equipment from FDA and CE. For example, biochemical detection products include reagents and instruments. We have imported reagents for some time, and everyone thinks that the import is too expensive, and the other is the instrument. That is to say, you can use the reagents of this manufacturer or other manufacturers. The instrument is open to reagents from different manufacturers. If I use imported instruments with domestic reagents, will my cost be reduced? As a result, a number of enterprises have emerged, such as Shanghai Long March and Mindray. Domestic IVD industry started from the production of substitute reagents, mainly biochemical reagents. Later, with the progress of technology, IVD products not only began to have domestic reagents, but also domestic instruments, which blossomed everywhere.
? Products are constantly emerging, and the national regulatory authorities should have a unified guiding standard for products. In China, SFDA was established, changed to CFDA, and now it is NMPA. The leader of IVD products is NMPA, and the hospital is Health and Health Commission. These two systems are different. In a hospital, you should listen to the standards of hospital evaluation.