The medical device certificate is the national certification of the safety and effectiveness of medical devices, and is the necessary proof of medical devices on the market. If the ECG network software is a kind of medical device, it needs to obtain a medical device registration certificate or a filing certificate in order to be legally sold and used in China. In addition, according to the "Measures for the Administration of Registration of Medical Devices", the obtaining of medical device registration and filing certificates needs to go through a strict technical review and approval process.
Therefore, if you intend to sell ECG network software in China, you need to apply for a medical device registration or filing certificate. During the application process, you need to comply with relevant laws, regulations and technical standards to ensure the safety and effectiveness of your product. In addition, it is recommended that you consult with relevant professional organizations or lawyers before applying to ensure that your application complies with laws and regulations.
In summary, ECG network software, as a type of medical device, requires a medical device license to be legally sold and used in China. During the application process, you need to comply with relevant laws, regulations and technical standards, and are advised to consult a professional organization or lawyer for guidance.