What are the conditions for applying for the registration of Class II and Class III medical devices without registration ? ( The conditions for registration of Class II and Class III medical devices are exempt from registration )
1. The basic principles, main functions, structure, materials, materials and intended uses of the medical devices applied for registration are the same as those for the medical devices that have been approved for registration.
2. The production enterprise has passed the medical device production quality management standard inspection or has obtained the medical device quality system certification, and the production enterprise can provide the test report approved by the original enterprise production condition review agency;
3. The medical device applied for registration is compared with the similar products that the enterprise has been approved to register and has passed the registration test. There is no security or effectiveness change, or although it involves changes in safety and effectiveness, the change and its The parts that cause other related safety and effectiveness changes of the products have been tested by the medical device testing organization;
4. The similar products of the company that have been approved for registration are monitored for medical device adverse events according to regulations, and no serious adverse events have been found;
5. The similar products of the same type of products that have been approved for registration have no unqualified records of product quality supervision and inspection by the (food) drug supervision and administration department within 1 year;
6. The overseas medical equipment has been approved by the overseas government medical equipment authority for listing.
Recommended reading: Introduction of SFDA Approval Department http://
Mini Camera Introduce
1. Wired camera
The advantages are that the technology is mature, the industrial Network Camera technology is directly transplanted, the signal interference is not feared, and it is stable and reliable;
The disadvantage is that the installation is complex and requires wiring. It can only be accessed through a computer. The scope of use is limited and it is not suitable for home use.
2. Wireless camera
The advantages are that there is no need for wiring, the installation and increase of cameras are relatively convenient, and the cost of Internet access is low;
The disadvantage is that it will be interfered by the signal, which may affect the definition and transmission speed of the picture.
Extended data
Now the technology of solar energy monitoring is mature, and solar energy can be used to solve the problem of power supply. Outdoor monitoring can also choose more advanced solar energy monitoring. Remote monitoring without power and network is no longer an imagination.
1. Simple installation: install by yourself without inviting construction personnel;
2. Adjustable angle: 360 degree rotation, no dead angle monitoring;
3. No electricity connection: solar power generation and built-in lithium battery power supply;
4. No wiring: no wall chiseling or decoration damage.
matters needing attention
The configuration of the solar power supply system requires the customer to provide the total power consumption of each load equipment,
It is necessary to know the local lighting conditions and the duration of continuous operation of the equipment
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