What are the conditions of medical equipment agent

Medical devices have a great help in the prevention and treatment of disease, now the development of China's medical care and some of the hospital equipment is updated very quickly. Medical devices as an important part of the pharmaceutical industry, many unscrupulous people see the medical device industry high-yield business opportunities, in the case of not obtaining the "Medical Device Business License", the illegal sale of Class III medical devices, then what are the conditions of the medical device agent? The following by me for you to answer one by one, I hope to help you. A, medical device agent conditions

should have the conditions of the medical device agent:

1, the operation of medical devices document requirements: "Medical Device Business License / Permit Application Form" a type of four copies of the applicant's qualification certificates copy of the name of the medical device business pre-approval notice.

2, personnel requirements: the person in charge of the business of medical devices should have a college degree or above to familiarize with the relevant laws and regulations of medical devices. At the same time, the person in charge of the enterprise, quality management personnel, quality inspection personnel can not be part-time other positions. Quality management personnel must have a college degree or above with more than one year of work experience.

3, office space and warehouse requirements: the business of medical equipment companies require office space for non-residential areas. Reagents use an area of not less than 60 square meters. Warehouse requirements for non-residential area of not less than 20 square meters for some of the products required to reach more than 100 square meters and the requirements of light, ventilation, dust, insect, moisture, rodent, pollution prevention, fire safety, testing and temperature and humidity regulation of facilities and equipment, as well as lighting facilities to meet the requirements. Storage of the implementation of zoning and classification management clearly marked and stored according to the product batch. The storage area should be divided into areas to be inspected, qualified products area, shipping area, non-qualified products area and other specialized places.

4, health management system and after-sales service system requirements: the operation of medical equipment companies should establish a sound health management system to ensure product safety in addition to the enterprise should have its business with the medical device products appropriate technical training and after-sales service capabilities or agreed to provide technical support by a third party.

Two, unlicensed sales of medical equipment how to punish

For the unlicensed sales of medical equipment, by the county-level drug supervision and management department ordered to stop operating, confiscate the illegal operation of the product and illegal income, illegal income of more than five thousand yuan, and impose more than two times the illegal income of more than five times the fine; no illegal income of less than five times the fine; no illegal income of less than five times the fine; no illegal income of less than five times the fine. The following fine; no illegal income or illegal income of less than five thousand yuan, and impose a fine of five thousand yuan or more than 20,000 yuan; constitutes a crime, be held criminally responsible. Amount of more than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the following fine; the circumstances are serious, within five years will not be accepted by the relevant responsible person and the enterprise to apply for a medical device license:

production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;

unauthorized to engage in the production of the second and third class of medical devices;

unauthorized to engage in the operation of the third class of medical devices. Class III medical device business activities. The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device production license or medical device license. Unauthorized use of large medical equipment configuration, by the people's governments at or above the county level, the competent department of health ordered to stop the use of health, give a warning, confiscate the illegal income; illegal income of less than 10,000 yuan, and impose a fine of 10,000 yuan above 50,000 yuan; illegal income of 10,000 yuan or more and impose a fine of more than five times the illegal income of 10 times the following fine; the circumstances of the case are serious, within five years, do not accept the responsibility of the person responsible for and the unit Proposed large medical equipment configuration license application.

Third, State will not be mandatory inspection of medical devices

According to the provisions of our medical device regulations, medical devices in the factory is required to carry out the inspection, and this inspection is mandatory, the inspection of qualified products can be used. Application for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Food and Drug Administration.

The export of Class II and Class III medical devices to China's foreign production enterprises, should be set up by its representative body in China or designated as an agent of the enterprise legal person in China, to the State Council food and drug supervision and management department to submit the application for registration and the registration of the applicant's country (region) competent authorities to authorize the sale of the medical device on the market documents.

The second class, the third class of medical device product registration application information in the product inspection report should be the medical device inspection agency issued the inspection report; clinical evaluation information should include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.

The above is for you to organize the medical device agent conditions are what the relevant content, I hope to help you. Engaged in the third class of medical equipment business, business enterprises should be located in the district of the municipal food and drug supervision department to apply for business license; and medical equipment business enterprises, the use of units in the purchase of medical equipment, should check the qualifications of the supplier and the qualification documents of medical equipment, can not be greedy for cheap in the unqualified place of business purchase.