Medical equipment agent conditions

Should have the conditions of the medical device agent: First, the operation of medical equipment documentation requirements: "Medical Device Business License / Permit Application Form" four copies of the applicant's qualification certificates copy of the medical device business name pre-approval notice. Second, the personnel requirements: the person in charge of the medical device business should have a college degree or above to familiarize themselves 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 concurrently other positions. Quality management personnel must have college education for more than one year of work experience. Third, the requirements of office space and warehouse: the office space of the medical device enterprise is required to be a non-residential residential area. 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 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 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, substandard products area and other specialized places. Fourth, the 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. "Supervision and Administration of Medical Devices Regulations" Article 30 engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of the Regulations of the proof of information.