Medical equipment agents need to have the conditions
One of the business of medical equipment document requirements: "medical equipment business enterprise license / permit application form" a type of four copies of the applicant's qualification certificates copy of the medical equipment business Enterprise name pre-approval notice.
Second, personnel requirements: the person in charge of operating medical devices business 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 more than one year of work experience. For Class II medical device product quality responsible person needs to have clinical medicine undergraduate degree or above, or attending physician or above title.
For Class III medical device products such as implantable devices Class III 6821, 6822, 6846, 6877, medical electronic devices Class III 6821, 6822, 6823,
6824, 6825, 6826, 6828, 6830, 6832, 6833, 6840, 6845, 6854, 6858, operating medical and sanitary materials and dressings supplies Ш category
6815, 6863, 6864, 6865, 6866, operating software category III 6870 quality managers need to be related to bachelor's degree or more 2 years of experience or intermediate or higher title.
General registration of a medical device business enterprise company enterprise requires more than 2 shareholders. The company personnel requirements at least 7 legal representative except. The person in charge of the enterprise, the supervisor or department manager, the person in charge of quality, full-time quality inspector, accountant, salesman, warehouse custodian and so on.
The inspector requires a specialist degree or above to engage in inspection of more than 3 years of work experience in the quality of the person in charge or a full-time quality inspector a secondary school degree or above in inspection of the professional as acceptance, after-sales personnel warehouse custodian
Third, the office space and warehouse requirements: the office space requirements for the operation of medical device companies are non-residential 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 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 to meet the requirements.
Storage of the implementation of zoning and categorization of management clearly marked and stored according to the product batch. Storage area should be divided into areas to be inspected, qualified products area, shipping area, non-qualified products area and other specialized places.
Four, health management system and after-sales service system requirements: the business of medical equipment companies should establish a sound health management system to ensure product safety in addition to the enterprise should have the ability to operate its medical equipment products with appropriate technical training and after-sales service or agreed to provide technical support by a third party.