I. Personnel, institutions and training
1. 1 The legal representative and person-in-charge of the enterprise should know the national and local laws, regulations and rules on the supervision and management of medical devices.
1.2 enterprises shall set up medical device quality management institutions or full-time quality management personnel.
Medical device enterprises operating in a single category shall have full-time quality management personnel.
Enterprises dealing in more than two kinds of medical devices shall set up a quality management organization, designate the person in charge of the quality management organization and have at least 1 quality management personnel.
1.3 the quality manager (referring to the person in charge of the quality management organization or full-time quality management personnel) should be familiar with the national laws, regulations, departmental rules and Beijing's regulations on the supervision and management of medical devices, be familiar with the technical standards of the products he deals with, and be responsible for the quality of the products he deals with, after-sales service and internal personnel training or assist the third party to complete the after-sales service and personnel training.
1.4 the quality manager shall have a college degree or above or an intermediate title in a relevant major recognized by the state.
1.5 The related major of quality manager is determined as:
1. Equipment category: medicine, nursing, medical devices, machinery, pharmacy, etc.
2. Equipment, appliances and large-scale medical equipment: medical instruments, computers, machinery, electronics, engineering, physics, etc.
3. Implantation, intervention and artificial organs and disposable sterility: medicine, nursing, electronics, etc.
4. Medical materials: polymers, medicine, nursing, pharmacy, biomedical engineering, etc. 5. Diagnostic reagents: chemistry, pharmacy and biomedical engineering.
6. Software category: computers, etc.
7. Fitting categories: optometry, biomedical engineering, clinical medicine, etc.
1.6 Enterprises engaged in implant, interventional and artificial organ products shall also be equipped with qualified medical technicians or professionally trained personnel.
1.7 When dealing in implant products, interventional products, artificial organ products and disposable sterile products, the enterprise shall organize health check-ups for those who come into direct contact with the products and provide health certificates.
1.8 Professional doctors or professionally trained personnel shall be equipped to operate the accessory products.
1.9 An enterprise shall have the technical training and after-sales service capabilities suitable for the medical device products it operates, or agree to provide technical support by a third party.
1. 10 The enterprise shall provide employees with relevant laws, regulations, rules, product technical standards, quality management knowledge and professional ethics training, and the training shall be planned.
Second, the business premises and storage conditions
2. 1 An enterprise shall have a business place that is suitable for its business scale and business scope and independent of the living quarters. The business premises shall be spacious, bright and clean, with fixed telephone and other office equipment, and the area of the stores operating medical devices shall not be less than 20 square meters.
2.2 The business area of the business premises (including warehouses with the same address) engaged in accessories products shall not be less than 50 square meters.
2.3 An enterprise that deals in contact lenses shall have an examination room, an optometry room, a wearing table and a sink in its business premises, and shall have good sanitary conditions. It should be equipped with an eye chart, ophthalmoscope, mirror box, computer optometry or comprehensive optometry, slit lamp and other instruments and equipment (hard contact lenses should be equipped with a corneal curvature meter).
2.4 The business premises of hearing aid enterprises should be equipped with reception rooms, medical examination rooms and hearing testing rooms. , and has good environmental and sanitary conditions. Should be equipped with professional hearing testing equipment or instruments, at least including audiometer, tuning fork, otology examination instrument and special equipment for hearing aid debugging with air-bone conduction detection function.
2.5 Having warehouses suitable for the scale and scope of business, the minimum use area of warehouses dealing in different types of products is as follows (except stores dealing in medical devices):
Equipment category: 20 square meters. Equipment and appliances: 30 square meters. Implants, interventional and artificial organs and diagnostic reagents: 10 m2. Medical materials: 50 square meters. Disposable aseptic category: 60 square meters. Single-machine operation of large medical equipment and software products can
There is no warehouse.
2.6 The warehouse should be divided into special areas such as waiting area, qualified product area, delivery area, unqualified product area and return area. The above areas should be clearly marked, and bulk goods can be hung with color signs. (Qualified and delivered with green sign; Use the yellow sign for pending inspection and return; Unqualified use red logo).
2.7 The walls, ceilings and floors in the warehouse shall be smooth and level, and the doors and windows shall be closed.
2.8 The environment around the warehouse should be clean and dry, free of dust, harmful gases and pollution sources.
2.9 The warehouse should be equipped with lighting, light-proof, ventilation, dust-proof, fire-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof and other safe electrical equipment, as well as storage facilities and equipment that meet the requirements of medical device product characteristics. To operate products with temperature and humidity requirements, the warehouse should have equipment for detecting and adjusting temperature and humidity, and facilities and equipment to ensure the safety and effectiveness of products during transportation.
2. The medical device products in10 warehouse should be placed in an orderly manner.
2. 1 1 specifies the storage area of effective products, which should be placed in a centralized way, with identification and expiration warning mechanism.
Iii. Management system and records
3. 1 The enterprise shall establish the following management systems:
Procurement system;
Procurement acceptance system;
Storage and custody system;
Entry and exit inspection system;
Quality tracking system;
Adverse event reporting system;
Non-conforming product handling system;
Effective product management system;
User complaint system;
After-sales service system;
Training system.
3.2 The enterprise shall establish the following records:
Records of the first batch of enterprises and the first batch of varieties;
Medical device procurement records;
Incoming acceptance record: at least including purchase date, supplier, product name, purchased quantity, specifications and models, factory number, production date, acceptance result, acceptance date and acceptance personnel;
Product maintenance records;
Outbound audit records;
Sales records: at least including sales date, sales unit, product name, production unit, specifications and models, production date, factory number, sales quantity and agent;
After-sales service records;
Quality tracking record: at least including product name, specification and model, manufacturer, production date, factory number, supplier, user name, address, end user, relevant contact person, contact information and tracking information;
Adverse event report records;
Handling records of unqualified products;
Effective product management records;
User complaint record;
Training records.
Four, medical device quality management documents
4. 1 medical device laws, regulations, rules and normative documents.
4.2 Medical device purchase and sale contract files (stores directly facing consumers do not need to establish sales contract files).
4.3 Medical device product qualification documents.
4.4 Supplier qualification documents.
4.5 User information.
4.6 enterprise employee files.
4.7 enterprise employee health examination files.