A. Personnel, organization and training
1.1 The legal representative of the enterprise, the person in charge should understand the national and local supervision and management of medical devices, laws, rules and regulations.
1.2 Enterprises should set up medical device quality management organization or full-time quality management personnel.
Operating a single category of medical devices business enterprises should have a full-time quality management personnel.
The operation of two classes (including two classes) of medical devices more than business enterprises should set up quality management organization, the appointment of quality management organization responsible for at least one quality management personnel.
1.3 The quality manager (the person in charge of the quality management organization or full-time quality management personnel) shall be familiar with national laws, regulations, departmental rules and regulations of medical devices and the relevant provisions of the supervision and management of medical devices in Beijing, familiar with the technical standards of the products in operation, responsible for the quality of the products in operation, after-sales service, training of internal personnel or assisting the third party to complete the after-sales service and personnel training. The staff training.
1. 4 The quality manager should have a college degree or above in relevant majors recognized by the state or a title of intermediate or above.
1. 5 The relevant specialties of the quality manager are identified as:
1. Device category: medicine, nursing, medical devices, machinery, pharmacy, etc.;
2. Equipment, apparatus and large medical equipment category: medical devices, computers, machinery, electronics, engineering, physics, etc.
3. Implantable, interventional and artificial organs category and disposable sterile category: Medicine, nursing, electronics, etc.
4, medical materials: polymers, medicine, nursing, pharmacy, biomedical engineering, etc.
5, diagnostic reagents: chemistry, pharmacy, biomedical engineering, etc.
6, software: computers, etc.
7, fitting: optometry, biomedical engineering, clinical medicine, etc.
1.6 business implantation, intervention and artificial organ products enterprises should also have qualified medical technicians or professionally trained personnel.
1.7 business implants, interventions and artificial organs and disposable sterile products, enterprises should be organized for direct contact with the product health checks and provide health certificates.
1.8 business fitting products should be equipped with specialized physicians or professionally trained personnel.
1.9 Enterprises should have the appropriate technical training and after-sales service capabilities for their medical device products, or agreed to provide technical support by a third party.
1.10 Enterprises should be staffed with relevant laws, regulations, rules and product technical standards, quality management knowledge, professional ethics training, training should be planned.
Two, business premises and storage conditions
2.1 Enterprises should have with the scale and scope of business appropriate, independent of the living area of the business premises, the business premises should be spacious, bright, clean, with a fixed telephone and other office equipment, medical equipment stores, the use of the area should be not less than 20 square meters.
2.2 Business fitting products, business premises area (including the same site warehouse) should be not less than 50 square meters.
2.3 operation of corneal contact lenses business, its business premises should be set up: examination room, optometry room, fitting table and hand-washing sinks, and has good hygiene conditions. Should be equipped with visual acuity meter, inspection glasses, lens box, computerized optometry or comprehensive optometry, slit lamps, etc. (rigid corneal contact lenses should increase the keratometer) instruments and equipment.
2.4 Businesses operating hearing aids, their business premises should be set up: reception room, medical examination room, hearing test room, and have a good environment and health conditions. Should be equipped with professional hearing test equipment or instruments, at least should include: audiometer with air bone conduction test function, tuning fork, otological examination instruments and special equipment for hearing aid commissioning.
2.5 with the scale and scope of operation of the warehouse, the operation of different categories of products warehouse minimum area as follows (except for the operation of medical equipment stores):
Instruments: 20 square meters. Equipment, apparatus category: 30 square meters. Implantation, intervention and artificial organs and diagnostic reagents: 10 square meters. Medical materials: 50 square meters. Disposable sterile class: 60 square meters. A single large medical equipment, software products can
No warehouse.
2.6 Warehouse should be divided into areas to be inspected, qualified products area, shipping area, non-conforming products area, return area and other special areas, the above areas should be clearly marked, bulk goods can be hung to show the color sign. (Qualified, shipping the use of green signs; pending inspection, return the use of yellow signs; unqualified use of red signs).
2.7 The walls, roof and floor of the warehouse should be clean, smooth, tightly structured doors and windows.
2.8 The environment around the warehouse should be clean, dry terrain, no dust, no harmful gases, no pollution sources.
2.9 Warehouses should have a safe use of electricity, lighting, light, ventilation, dust, fire, moisture, mold, pollution, insects, rodents and other equipment, as well as storage facilities and equipment to meet the requirements of the characteristics of medical devices. Operation of temperature and humidity requirements of the product, the warehouse should be tested and regulate the temperature and humidity of the equipment, and have to ensure that the product is safe in the transportation process, effective facilities and equipment.
2.10 medical device products in the warehouse should be placed in order.
2.11 clear expiration date product storage area, expiration date products should be centrally placed, to make the mark and the expiration date of the early warning mechanism.
Three, management systems and records
3.1 enterprises should establish the following management systems:
Purchasing system;
Incoming inspection system;
Warehousing and storage system;
Incoming and outgoing double-checking system;
Quality tracking system;
Adverse event reporting system;
Non-conforming products handling system;
Adverse event reporting system.
Failed product handling system;
Expiry date product management system;
User complaint system;
After-sales service system;
Training system.
3.2 Enterprises should establish the following records:
The first enterprise and the first species records;
Medical device procurement records;
Incoming acceptance records: at least should include the date of purchase, the supplier, the product name, the number of purchases, specifications, model number, factory number, the date of production, the results of acceptance, the date of acceptance, acceptance of the acceptance of the personnel;
Product care records;
Outbound review records;
Sales records: at least should include the date of sale, sales unit, product name, production unit, specification model, date of production, factory number, sales quantities, the person in charge;
After-sales service records;
Quality Tracking Records: at least should include the product name, specification model, manufacturer
Adverse event report records;
Unqualified product handling records;
Expiry date product management records;
User complaint records;
Training records.
Four, medical device quality management files
4.1 Medical device laws, regulations, rules and normative documents files.
4.2 medical device procurement, sales contract files (direct consumer-oriented stores may not establish sales contract files).
4.3 Medical device product qualification files.
4.4 Supplier qualification files.
4.5 User files.
4.6 Enterprise employee files.
4.7 Employee health check files.
5.