According to the "Medical Devices Supervision and Administration Regulations", medical devices are divided into three categories, of which Class I medical devices refers to the human body for the prevention, diagnosis, treatment, monitoring or mitigation of disease function of machinery, equipment, apparatus, materials or other categories of products. Commonly used medical devices in stomatology mainly include stomatoscope, oral routine diagnostic instruments (such as trays, mouth poles, examination needles, retractors, etc.) and so on. And these instruments need to be in the State Drug Administration for the record and obtain the appropriate record certificate in order to use legally.
In addition to Class I medical devices, Class II medical devices and Class III medical devices also have different filing requirements, such as the need to submit relevant documents, qualifications and certifications.