1. Qualification of production enterprise: 1. Business license (three certificates in one) 2 copies of organization code certificate and tax payment certificate. Production license. Product registration certificate.
Qualification of manufacturing enterprise: 1. Business license (three certificates in one) 2 copies of organization code certificate and tax payment certificate. Production license. Authorization and integrity. Purchase agreement.
Reagents also belong to medical devices, refer to the relevant management regulations of medical devices.
Medical devices are divided into class I, class II and class III. To determine which category they belong to, please refer to the 6840 subdirectory of in vitro diagnostic reagent classification.
1. Regulations on the Supervision and Administration of Medical Devices (revised on 20 17) and Measures for the Administration of Medical Device Registration.
The first category of medical devices shall be subject to product filing management, and the second and third categories of medical devices shall be subject to product registration management.
2. Regulations on Supervision and Administration of Medical Devices (revised on 20 17) and Measures for Supervision and Administration of Medical Device Production (revised on 20 17)
The first category needs to be filed, and the second and third categories need permission.
3. Measures for the Supervision and Administration of Medical Devices (revised 20 17)
4. According to the risk degree of medical devices, medical devices are classified and managed.
There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.
Scientific research reagents were originally born in the laboratory. Teaching, scientific research, production inspection and other laboratory departments urgently need some analytical reagents and chemical reagents for qualitative and quantitative analysis of substances, so the production of scientific research reagents came into being. Scientific research reagents are not only used to determine and verify the composition and changes of the material world, but also used to develop and create new substances. They have always been known as "scientific eyes" and "quality yardsticks".
With the increasing demand for scientific research experiments, scientific research reagents tend to be diversified and high purity. The R&D experiments and manufacturing in various industries of the national economy are developing in the direction of high precision, and the variety and demand of scientific research reagents are gradually increasing. After 1950s, emerging industries such as electronics industry, nuclear industry and aerospace industry, and emerging scientific and technological departments such as life science, materials science and bioengineering. With the rapid development, scientific research reagent enterprises are required to provide thousands of new kinds of high-purity and ultra-pure reagents to meet the needs of determination and verification of new substances.