Classification and definition of medical devices

Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software. It can be seen that the scope of medical devices is very broad. Its main purpose is to diagnose, prevent, monitor, treat or alleviate diseases, and so on.

China compliance

How to Access the China Electric Power Communication Network for Power-Specific Communication Equipment

In order to manage the power-specific communication equipment connected to the power communication network, ensure the safety of the power communication network, and meet the needs of safe, stable and economical operation of power production. State Grid Corporation of China and Ministry of Industry and Information Technology of China have formulated the ‘Administrative Measures for the Access of Electric Power Special Communication Equipment to the Network’ in accordance with relevant regulations
Power communication equipment refers to equipment with special requirements that is used in the power system and has a direct impact on power operation, such as power dispatch exchange machine, power line carrier machines, and power special optical cables.
According to the provisions of State Grid Corporation of China, the Network Access License system shall be implemented for the power-specific communication equipment connected to the power communication network. All equipment connected to the power communication network must have a Network Access License issued by State Grid Corporation of China. Equipment without a license shall not be used in the power communication network.
The power-specific communication equipment connected to the power communication network must comply with the relevant standards and specifications of the Chinese power industry.

1. To apply for a Network Access License, the following conditions must be met:

Ⅰ. Comply with China‘s industrial policies and relevant regulations;

Ⅱ. Comply with relevant Chinese standards and industry technical standards;

Ⅲ. Have an effective quality assurance system.

2. To apply for a Network Access License, you need to provide an application form and the following materials:

 ①. Company profile: business license (copy), personnel organization, affiliation, etc.

②. Production overview: production capacity, production conditions, instrument equipment, quality assurance system, sales and after-sales service measures.

③. Product overview: corporate standards, technical data, cost analysis, equipment appearance and photos of internal structure, etc.

④. User list: List of typical users of the equipment used in the power system (except new equipment), commissioning time, place of use, usage, contact information (including e-mail).

⑤. Enterprises that distribute imported communication equipment, in addition to meeting the above four requirements, also need to provide various relevant documents that China allows to import communication equipment.
(Except for the certification materials, the above materials must be in Chinese. Non-Chinese manufacturers can entrust their branches or agents in China to apply.)

3. The application process for applying for a Network Access License:

 1) Submit the information to the Network Access Receiving Department.

2) The quality inspection department conducts random inspection on the products submitted for inspection.

3) The Network Access Receiving Department will review the materials applied by the enterprise and the results of the random inspection.

4) The Network Access Receiving Department conducts investigations on enterprises and users to understand the use of products.

5) After the approval, the enterprise will be issued a Network Access License.

6) The enterprise shall go to the acceptance department to obtain the Network Access License.
(The Network Access License is uniformly printed and issued by The Network Access Receiving Department)
The Network Access License is valid for two years, and an application for renewal is required three months before the expiration of the validity period. Failure to apply for a permit will expire on its own

Deeplight has completed the application for Network Access Licenses for power-specific communication equipment for many companies. If you need it, you can consult us. We will provide the most professional, reliable and accurate services.