Medical equipment business license process:
1, name check
2, for business license
3, for medical equipment business license
4, change the scope of business (add the second class, the third class of medical equipment business scope)
Medical equipment business license for the required materials:
1, Relevant medical graduates of college (including college) diploma product quality supervision and testing personnel (one of the quality testing responsible);
2, quality supervision and testing personnel ID card and a copy of the certificate of graduation, work resume; (Food and Drug Administration teacher to come over to the site to verify the interviews need to provide the relevant testing personnel ID card and the original certificate of graduation, and I was there);
3, the sale of medical devices to the other manufacturer of the company's business license, medical device manufacturer's license;
4, the sale of medical devices to the other manufacturer of medical device registration certificate, medical device registration form;
5, the sale of medical devices to the other manufacturer of the commissioned sales of authorization;
Laws and regulations on the operation of medical equipment There are "medical device standards management approach", "large medical equipment configuration and use of management approach", "medical device recall management approach", "the use of medical equipment quality supervision and management approach" and other laws and regulations. China's relevant laws and regulations, can not be illegal to operate medical devices and their supervision and management.
"The Chinese people*** and the basic medical care and health promotion law" Article 99 Violation of the provisions of this law, without obtaining a license to practice medical institutions without authorization, by the people's government at or above the county level, the competent department of health ordered to stop practicing, confiscate the illegal income and medicines, medical equipment, and impose a fine of more than five times the illegal income of more than twenty times the illegal income, the illegal income of less than 10,000 yuan , calculated on the basis of ten thousand yuan. Violation of the provisions of this Law, forgery, alteration, trading, leasing, lending of medical institutions practice permit, by the people's governments at or above the county level, the competent department of health and health ordered to correct, confiscate the illegal income, and impose a fine of more than five times the illegal income of more than fifteen times the illegal income of less than 10,000 yuan, according to the calculation of 10,000 yuan; the circumstances are serious, the revocation of the license to practice medical institutions.