1. Three certificates of medical device sales enterprises are business license, production license of the enterprise, the registration certificate of the sales product (with the approval form).
2. medical devices: medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is mainly through physical means, not through pharmacological, immunological or metabolic means, or although these modalities are involved, but only to play an auxiliary role; its purpose is to disease. ancillary; the purpose of which is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of samples from the human body.