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

Classification and definition of medical devices

Wireless medical device export

How do terminal products enter China Mobile Communications Group Co.,Ltd (CMCC) stock?

1. Why should LTE terminals be included in CMCC stock?

1).In the stock LTE terminal can enjoy the subsidy policy of CMCC;

2).In the stock LTE terminal can be sold in CMCC‘s own business hall;

3).In the stock LTE terminal can participate in CMCC‘s centralized procurement bidding;

4).In the stock LTE terminal have the opportunity to cooperate with the terminal company provincial agents or national agents and other agents;

5).In the stock LTE terminal, you can participate in the group centralized procurement or become the agent product of the group terminal company, etc.

At present, the CMCC stock entry test is quite difficult even for large manufacturers. If there is no special person to follow up, communicate in time and assist in dealing with problems, it will take a long time to enter the stock evaluation stage, and it often takes several rounds of tests for several months to complete the stock entry. In addition to the cost increase caused by the extension of the testing process itself, it will also miss the best time to market the product, which is an incalculable loss to any manufacturer.

In this regard, Deeplight has a special person to follow up the project from the beginning to the end. At the same time, we also have a good cooperative relationship with CMCC, which can help customers better enter the testing stage and save manufacturers a lot of energy and time.

The prerequisite preparations and contents for CMCC to enter the stock are:

The product‘s CCCSRRCCTA certification, and need to have their own TAC code, and some need to attach SAR test report.

2. CMCC enters the stock application process

1) Submit test application

Submit product terminal information and test application in the CMCC TSP system before the 2nd of each month.

Samples delivery test after approval

2) Samples delivery

Issue a test report after passing the test

3) Submit a stock application

If the report meets the stock entry standards, submit an application for stock entry before the 10th of each month (online application + written application)

4) CMCC shortlist test

After passing the review, enter the shortlist test

3. CMCC enters the stock testing process

4. The contents of the terminal test include:

1).Wireless communication

Protocol, RF conformance, RRM conformance, IOT, machine card compatibility, etc.

2).Business application

Various basic services, client services, local functions

3).Software reliability

MTBF, power consumption, concurrency, exception, touch screen performance, local performance, stress test

4).Hardware reliability

OTA, audio, CMMB RF, structure

5).Field test

Field test in 5 cities including Beijing, Nanjing and Hangzhou

6).User experience

User real use scenario test

5. the LTE part of the stock test standards:

For frequency bands: TD-LTE Band 38/39/40/41 LTE FDD Band7

Protocol conformance: 3GPP TS36.523-1

RF conformance: 3GPP TS36.521-1

RRM conformance: 3GPP TS36521-3

USIM/UICC conformance: 3GPP TS31121

IOT: China Mobile TD-LTE terminal NS-IOT test specification

The above are some of Deeplight‘s answers to CMCC‘s entry into stock. If you need it, feel free to come and ask for a quotation. We will provide the most professional, reliable and accurate testing and certification services.