1, company business license, this is the most basic thing.

2, testing and certification of various instruments, you have to know that everything must be tested and certified before it can be sold, such as exporting to Europe, the European standard CE.

3. Medical device business license is an essential document for medical device business enterprises. Without this certificate, the state is not allowed to sell. If it is found out, not only the instruments will be confiscated, but also a fine of up to several hundred thousand, because several hundred thousand will be fined tens of thousands.

According to national regulations, Class I and Class II medical devices do not need to be filed, while Class III medical devices are the highest level medical devices and must be strictly controlled. They refer to medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. The medical device business license is for Class III, so whether there is a license or not has a great influence.

Extended data:

According to the regulations, an enterprise should set up technical training and after-sales service departments/personnel suitable for its business scale and variety, or agree to provide technical support by a third party.

The person in charge of quality should have a college degree or above in medical devices or related majors, or a junior technical title or above in related majors recognized by the state (related majors refer to science, engineering, agriculture, medicine and pharmacy majors such as machinery, electronics, medicine, pharmacy, bioengineering, chemistry, nursing and computer, the same below).

The person in charge of quality should be familiar with the laws and regulations on the supervision and management of medical devices and the relevant knowledge of the medical devices handled, and have certain practical experience.

The person in charge of the quality management institution shall have a bachelor's degree or above in medical devices or related majors or an intermediate or above technical title in related majors recognized by the state, and have more than 2 years of relevant work experience in medical devices.

Baidu Encyclopedia-Regulations on the Supervision and Administration of Medical Devices