A medical device license process:
1, name check;
2, for the business license;
3, for the medical device license;
4, to change the scope of business (add the second class, the third class of medical devices business scope).
Two, 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 experience; (Food and Drug Administration teacher over the site verification interviews) (The Food and Drug Administration teacher to come to the site to verify the interviews need to provide the original ID card and diploma of the relevant testing personnel, and in person);
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 the medical device registration certificate, the registration form of medical devices;
5, the sale of medical equipment The other manufacturer's commissioned sales authorization.
Legal basis: "supervision and management of medical devices regulations" Article 66 of the following circumstances, by the people's government at or above the county level food and drug supervision and management department shall order correction, confiscation of illegal production, operation or use of medical devices; illegal production, operation or use of medical devices less than 10,000 yuan of the value of the goods and impose a fine of 20,000 yuan or more than 50,000 yuan; the value of the goods, operation or use of medical devices less than 10,000 yuan and impose a fine of 20,000 yuan or more than 50,000 yuan. Above 50,000 yuan fine; the value of more than 10,000 yuan, and impose a value of more than 5 times the amount of 10 times the amount of fine; the circumstances are serious, ordered to suspend production and business, until the original licensing department revoke the registration of medical devices, medical device manufacturing license, medical device license:
(a) the production, operation and use of medical devices do not meet the mandatory standards or do not meet the registered or filed by the Product technical requirements of medical devices;
(b) medical device manufacturers do not follow the registered or filed product technical requirements of the organization of production, or not in accordance with the provisions of these regulations to establish a quality management system and maintain effective operation;
(c) the operation and use of no qualification documents, expired, expired, obsolete medical devices, or the use of not legally registered Medical devices;
(d) food and drug supervision and management department ordered in accordance with the provisions of this regulation to implement the recall or stop operating, but still refused to recall or stop operating medical devices;
(e) entrusted to do not have the conditions of this regulation of the production of medical devices, or the production of entrusted parties to the management of the production of behavior.
Medical equipment business enterprises, the use of units to fulfill the provisions of these regulations such as purchase inspection obligations, there is sufficient evidence to prove that it is not aware of the operation, use of medical devices for the first paragraph of the previous paragraph, the third paragraph of the circumstances of the medical device, and can truthfully explain the source of its purchase, can be exempted from punishment, but shall be confiscated according to law for the operation, use of medical devices do not meet the statutory requirements.