2. What are the specific requirements for applying for the license of the third type medical device business enterprise? The finer the wholesale, the better, especially the personnel, which are urgent

2. What are the specific requirements for applying for the license of the third type medical device business enterprise? The finer the wholesale, the better, especially the personnel, which are urgently needed. 1. Document requirements for operating medical devices: application form for license of medical device operating enterprise in quadruplicate, copy of applicant's qualification certificate, and notice of pre-approval of medical device operating enterprise name. 2. Personnel requirements: the person in charge of the medical device enterprise should have a college degree or above and be familiar with the relevant laws and regulations of medical devices. At the same time, the person in charge of the enterprise, quality management personnel and quality inspection personnel cannot hold other positions concurrently. Quality management personnel must have a college degree or above and more than one year's work experience. For Class II medical device products, the person in charge of quality must have a bachelor's degree or above in clinical medicine, or a title of attending physician or above. Take three types of medical device products as examples, dealing in implantable devices (ш 682 1, 6822, 6846, 6877) and medical electronic devices (ш 682 1, 6822, 6823, 6824, 6825, 6826). Medical and health materials and dressings (consumables) management (ш 6815,6863,6864,6865,6866) and software (ш 6870), quality management personnel need a bachelor's degree or above in related majors, with more than 2 years of work experience or intermediate titles. Generally, a registered medical device enterprise company needs more than 2 shareholders. In addition to the legal representative, the company needs at least 7 employees. Responsible person, supervisor or department manager, quality director, full-time quality inspector, accountant, salesman, warehouse keeper, etc. Requirements for inspectors: College degree or above, more than 3 years inspection experience (quality supervisor or full-time quality inspector) 1 person; Technical secondary school degree or above, inspection major, acceptance and after-sales personnel (warehouse keeper) 1 person. 3. Requirements for office space and warehouse: The office space for medical device enterprises is required to be a non-residential area. The reagent use area is not less than 60 square meters. Warehouse requirements: non-residential residential area, not less than 20 square meters, some products require more than 100 square meters, and the requirements are light-proof, ventilation, dust-proof, insect-proof, moisture-proof, rodent-proof, pollution-proof, fire safety, detection, temperature and humidity adjustment and lighting facilities meet the requirements. Storage shall be managed by division and classification, clearly marked, and stored by product batch. The reservoir area should be divided into waiting area, qualified product area, delivery area, unqualified product area and other special places. Four. Health management system and after-sales service system Enterprises engaged in medical devices shall establish and improve the health management system to ensure product safety. In addition, the enterprise should have the technical training and after-sales service ability suitable for the medical device products it operates, or agree to provide technical support by a third party. I hope it helps you. The information comes from the medical device operation requirements of Osta medical devices.