The difference between health care equipment and medical devices

Documentation, mainly under different departments, medical equipment belongs to the Food and Drug Administration management, relative to health care equipment, the quality assurance of the product to be more stringent, the application for medical equipment to apply for "Medical Device Manufacturing License", "Medical Device Business License", the product is distinguished according to the three major categories, a class of products is the easiest to apply for (the city level can be obtained for approval), the second class (product contact with the surface of the skin) , the provincial level to obtain approval. Class III (X-ray machines and other interventions in the human body products) is very difficult, to the national approval to pass, to obtain the appropriate "medical device product registration certificate.