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

What needs to be done to enter the China Telecom stock?

1. China Telecom‘s stock entry is roughly divided into two types

1) Entering A stock, you have the opportunity to get subsidies from China Telecom, which can be sold in the terminal business hall of China Telecom.

Submit the test application and materials on the China Telecom Terminal Evaluation Management System, and send the samples to the testing center for testing and certification after passing the review.

2) Entering B stock, it can only be displayed on the China Telecom website

It is necessary to submit the materials according to the requirements for entering the China Telecom terminal B stock to apply for the stock, and only need to perform a simple stock entry test

Before entering the stock, China Telecom‘s terminal products must complete the manufacturer‘s filing process and obtain the terminal manufacturer‘s management platform account; mobile phone terminals must pass the test of the Ministry of Industry and Information Technology, and obtain the network access license(NAL/CTA certificate), model approval certificate(SRRC certificate) and CCC certification.

Entering A stock must pass the test of the testing center. Before entering the stock, the sales department of China Telecom Tianyi headquarters must review the packaging of China Telecom, Tianyi and other logos and the location of the fuselage LOGO vector diagram

2. China Telecom needs to conduct basic product testing before launching products into stock

1. Testing of packaging and appearance parts

The terminal packaging box shall indicate the network access license number.

The terminal packaging box must indicate the standard product name, and the product name must be consistent with the product name on the 3C certification.

The SAR value must be indicated on the manual of the mobile phone terminal

The mobile phone terminal manual must indicate the list of environmental protection labels and the service life.

The terminal must be affixed with a network access license label.

2. Software part of the test

The software version of the prototype should be consistent with the version in the stock data submitted by the manufacturer.

There shall not be any malicious deduction software, games or operations that lead to malicious deduction in the terminal.

All functions in the terminal must be able to be used normally, and the function points shall be tested by sampling.

The call timing function of mobile phone terminals must start timing when the other party answers the call.

3. Review of data information

Product information and other related materials

Mobile phone terminals must implement the China Telecom platform self-registration function in the mobile phone according to China Telecom‘s specification requirements.

3. The CDMA terminal test is divided into two parts: telecom test and entrusted test.

1. Telecom testing includes:

Lab test

Instrument test [RF, MEID]

Power consumption test

Business test

Basic functional test

UI interoperability concurrent testing

JAVA test

Machine card compatibility test

Live network test

2. Delegated tests include:

Brew RR Certification Test

GPS One Test

Dual Standby Test

4. China Telecom Mobile Terminal Test Standard

China Telecom Mobile Terminal Test Method - MMS Test Volume

China Telecom Mobile Terminal Test Method - Browser Volume

China Telecom Mobile Terminal Test Method-LBS Function Volume

China Telecom Mobile Terminal Test Method - International Roaming Volume

China Telecom Mobile Terminal Test Method - QChat Function Volume

China Telecom Mobile Terminal Test Method-UI Volume

etc.

5. Frequency band requirements

China Telecom‘s 4G mobile terminal modes are mainly: SVLTE and SRLTE

When roaming, currently mainly roaming in WCDMA and GSM mode, the next step will consider LTE roaming, and may adopt CSFB mode when roaming

6. Application process

(1) Submit the test application through the website

(2) Application confirmation and acceptance

(3) Prototype sent for testing

(4)Pre-test

(5)Formal test

(6)Submit test report

(7)The group company organizes the review of test results (the group company organizes an expert group to conduct report and problem review, including rectification requirements)

① If the review is passed, go to the next step

②If the review fails, the test problem set and handling opinions will be released, and the manufacturer will rectify it. (Feedback reasons and solutions; non-terminal problems need to be communicated and negotiated.)

(8)Release test report

(9)Model into stock

If you have products that need to enter China Telecom stock, you can come to consult us, we have the most professional, reliable and accurate testing and certification services. We can solve problems for customers and save a lot of time and energy.