Medical device means an instrument, equipment, appliance, material or other article, including the required software, used alone or in combination on the human body; its use on the surface of the human body and in the body is not obtained by means of pharmacology, immunology or metabolism, but there may be the participation of these means and play a certain supporting role; its use is intended to achieve the following intended purposes: (a) the prevention, diagnosis, treatment, custody, alleviation of disease; (b) the diagnosis, treatment, custody, alleviation, compensation of injury or disability; (c) the study of anatomical or physiological processes, replacement, regulation; (d) pregnancy control, treatment, guardianship, and mitigation of disease; (ii) diagnosis, treatment, guardianship, mitigation, and compensation for injury or disability; (iii) study, substitution, and regulation of anatomical or physiological processes; and (iv) pregnancy control. Medical devices must be manufactured and sold only after obtaining a certificate of registration from the FDA. Your company's production of products that do not belong to the medical device is not subject to registration by the Drug Administration, if it belongs to the medical device should be registered before production and sales, medical device packaging State Drug Administration has management regulations online can be queried
Not belonging to the medical device products on the outer packaging of the prompt use of the scope of vocabulary: such as lumbar pain is suitable for use, menstrual cramps are suitable for use, etc. is not permitted to be used, what is the product Go online to check the national product standards can be,