In accordance with the current "Regulations for the Supervision and Administration of Medical Devices", medical devices, refers to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is obtained mainly through physical and other means, not through pharmacology, immunological or metabolic means, or which, although involved in such means, play only a supporting role; and which are intended to:
(i) diagnose, prevent, monitor, treat, or mitigate disease;
(ii) diagnose, monitor, treat, mitigate, or functionally compensate for injuries;
(iii) test, replace, regulate, or support;
(iv) life support or maintenance;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.
What you see in the market (including and not limited to online sales and brick-and-mortar stores), those who are selling medical devices, should be legally obtained medical device registration or filing certificate.
There are many different types of medical devices, including large medical devices such as CT, magnetic **** vibration and other imaging equipment, as well as syringes, surgical instruments, dental prostheses, biochemical test reagents, etc., as well as tongue depressors, condoms, etc., most of which are used by professionals in health care institutions, and some of them can be used for their own purposes.
That. Is there a legal concept for in vitro diagnostic reagents? There is.
In accordance with the Measures for the Administration of Registration of In Vitro Diagnostic Reagents issued by China in 2014, in vitro diagnostic reagents (IVDs), managed as medical devices, include reagents, kits, calibrators, and quality control products used for the in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation, and health status evaluation. They can be used alone or in combination with instruments, apparatus, equipment or systems.
Nowadays, in vitro diagnostic reagents are basically needed for disease prevention and clinical diagnosis and treatment. Whether it is blood, urine and stool three routine testing, or the identification of viral and bacterial infections, or heart, liver, kidney, blood vessels, immune function tests, etc., are inseparable from the in vitro diagnostic reagents.
In vitro diagnostic reagents, are in accordance with the medical device to regulate?
Not exactly.
In our country, most of the in vitro diagnostic reagents are managed according to medical devices, and some in vitro diagnostic reagents are managed according to drugs.
The ones managed according to drugs are mainly in vitro diagnostic reagents used for blood screening and in vitro diagnostic reagents labeled with radionuclides, which are not medical devices.
All listed in vitro diagnostic reagents should be registered or filed by the Food and Drug Administration, and obtain the relevant medical device registration certificate or filing certificate.
This is a key factor in distinguishing diagnostic reagent products from in vitro diagnostic reagents. To check their registration number Oh, and then use the number on the product corresponds to the State Food and Drug Administration official website data query in the information. Right, and then look at the packaging, product integrity and so on. If you don't, it must not be!