1, the person in charge of the enterprise shall have secondary school (high school) or above, familiar with the supervision and management of medical devices and the rules and regulations of the medical device products.
2, the quality of business enterprises should have college education or intermediate title or above, familiar with the supervision and management of medical devices and medical devices supervision and management of laws and regulations and the quality standards of the medical device products operated by the training and to meet the requirements of the examination.
3, the enterprise should be set up with the scale of operation and business scope of the quality management and inspection (verification) organizations, the exercise of quality management and quality verification functions. Enterprises should have a special quality inspection site and the corresponding testing equipment and measuring instruments, and in the validity of the use.
4, the enterprise should be equipped with relevant professional after-sales service personnel, with the scale of operation and business varieties appropriate maintenance and other after-sales service capabilities, or agreed by the third party to provide technical support.
5, the enterprise should be equipped with quality inspection (verification) personnel (not less than two people). Business enterprise quality inspection (verification) personnel should have a high school education, familiar with the quality standards of the products operated, and after training and qualified for duty, with the products operated by the ability to carry out inspection (verification).
Enterprises responsible for quality, quality inspectors shall not be outside part-time, where the employment of retired, retired, resigned, etc., must be provided by the original unit to provide relevant proof.
6, the enterprise should establish personnel health records. Direct contact with sterile equipment personnel should be annual health checks, found to be suffering from infectious diseases, skin diseases and mental illness should be transferred in a timely manner.
Facilities and equipment
1, with the scale of operation of the business premises. Business area is generally not less than 30 square meters; warehousing area should be compatible with the scale of business. Residential housing can not be used as a business office, business, storage space.
2, with the scale and scope of operation of relatively independent business premises; clean surrounding environment. Business address should be consistent with the registered address.
3, the business front of the display of medical equipment products should be classified according to species, specifications and other neatly arranged, category labels should be placed accurately and clearly written.
4, the storage of sterile medical devices should be consistent with the product standard storage provisions.
5, warehouses and storage facilities should be in line with the operation of medical equipment storage, storage requirements, with fire, moisture, dust, rodent, insect facilities.
6, the warehouse should be clean, tightly structured windows and doors, the ground level, no gaps, and separate from business, office, living areas.
7, the storage of medical devices to implement zoning and classification management, the division of qualified areas, unqualified areas, to be inspected and return areas, and according to product categories, batch storage; expiration date and other types of marking should be clear; the warehouse should be compatible with the storage requirements of the equipment and facilities, and keep intact, such as thermo-hygrometer, padding, shelves, light or temperature control equipment, should meet the safety requirements of the lighting, fire prevention, ventilation Facilities.
8, with the scale and scope of operation of the storage conditions, storage, handling of medical equipment with special requirements, there should be a special warehouse and storage conditions.
9, part-time or professional agent of medical equipment products should be relatively independent of the business and warehousing space or area, the quality of medical equipment management organization or management personnel and management system, the display and storage of medical equipment products shall not be mixed with other products.
System and management
1, the enterprise should be in accordance with relevant national and local regulations, the establishment of a sound and necessary management system, and strictly enforced.
Systems include: ① quality responsibility at all levels; ② product certification system; ③ product quality verification, storage, maintenance and warehousing review system; ④ expiration date of the product management system; ⑤ unqualified product management system; ⑥ purchase and marketing records file system; ⑦ first business variety of quality audit system; ⑧ document management system; ⑨ product after-sales service system; ⑩ quality tracking and adverse event reporting system.
2, in the procurement control, purchase and acceptance, warehouse management, quality accidents, adverse
Adverse event reporting and defective products handling and other key aspects of the development of relevant procedural documents.
3, the collection and preservation of laws, rules and regulations related to business operations
4, the collection and preservation of technical standards at all levels related to the products operated.
5, the enterprise for the first time the supply unit must confirm its legal qualifications, verify the "Medical Device Manufacturer License", "Medical Device Product Registration Certificate", product certification and other relevant documents.
6, the enterprise should confirm the ability of the first supply unit to fulfill the contract, ask for product quality standards, sign a quality assurance agreement, and save the relevant supporting documents, the establishment of file management.
7, quality verification personnel should be based on the relevant standards and contracts on the quality of medical devices batch by batch verification, and have records.
8, the custodian is familiar with the quality and performance of medical devices and storage conditions, with the validation of the personnel signed the entry voucher acceptance. Abnormal quality, fuzzy sign of medical devices should be rejected.
9, the medical equipment inbound acceptance, outbound sales should be carefully recorded.
(Sterile, implantable medical devices shall be special book).