Project terms Inspection content Full marks Coefficient score Inspection method Deduction reason
Part I
Institutions and personnel 1 The person in charge of the enterprise or drug store manager (store manager) should be familiar with the state supervision and management of medical devices regulations, rules and have the appropriate professional knowledge of the enterprise business product quality leadership responsibility, and shall not also be the head of the quality management organization or full-time quality management personnel. Professional knowledge, the quality of the products operated by the enterprise is responsible for the leadership, and shall not also be the head of the quality management organization or full-time quality management personnel. Individual industrial and commercial households shall not be engaged in Class III medical device products business (except for corneal contact lenses and nursing fluid business and licensed drug retail chain headquarters under the stores part of the business). Negative items Paper-based examination or interview on site.
2 Enterprises should be set up with the scale and scope of operation of the quality management organization or full-time quality management personnel, the exercise of quality management functions, a clear division of responsibilities, of which: (1) the operation of a single category of medical device companies, drug retailing and operating devices can set up a full-time quality management personnel. (2) professional agent of medical device business enterprises shall set up quality management organization, under the quality management group (staff) and quality acceptance group (staff), of which not less than one person for each group in the second category of enterprises, and not less than two persons for each group in the third category of enterprises. (3) operating a comprehensive class of medical devices business enterprises should be set up quality management organization, under the quality management group and quality acceptance group, each group of not less than 3 people. Negative Verification of institutional setup documents and staff roster.
3 Quality management refers to the person in charge of the quality management organization or full-time quality management personnel, should have the relevant professional qualifications of their business product categories, familiar with the national and provincial supervision and management of medical devices related to the laws and regulations, rules, normative documents and relevant professional knowledge, familiar with the technical standards of the products operated. The person in charge of the quality management organization or full-time quality management personnel shall be on duty and shall not work part-time in other units. Negative Verification of the appointment documents of relevant personnel and the existence of part-time jobs, etc. On-site paper examination or interview.
4 operating comprehensive or professional agent of large medical equipment, medical materials, disposable sterile class and implantable, interventional and artificial organ class medical device enterprises, the person in charge of the quality management organization should have the relevant professional state-recognized undergraduate degree or intermediate or above technical title, and more than three years of experience in medical device business quality management. Professional agent of the second, third category of medical devices in the device class, equipment and apparatus class, software class, testing and fitting class of enterprises, quality management institutions or full-time quality management personnel shall have relevant professional state-recognized college degree or above or junior or above technical title, and have more than 1 year engaged in the work of medical equipment practice experience. The full-time quality management personnel of retail pharmacies operating a single category and part-time medical devices shall have a nationally recognized junior college degree or above in the relevant specialty or be concurrently appointed by the full-time quality management personnel of drugs. Negative items Check the original academic or title (qualification) certificates, work resume and understand their previous work in medical devices.
Items Terms Inspection Content Full marks Coefficient Score Inspection Method Deduction Reasons
Part I
Institutions and personnel
5 enterprises engaged in the quality of the acceptance and sales of personnel should be familiar with the national supervision and management of medical devices rules and regulations and related technical standards, and be able to independently solve the specific quality problems in the process of operation.
The quality acceptance and sales of Class II medical devices shall have a nationally recognized secondary school education or above, or more than junior technical title or have a medical device internal auditor qualification certificate.
Operation of Class III medical device quality acceptance and sales personnel should have a nationally recognized college degree or more related professional qualifications or technical title above the intermediate level or with a medical device internal auditor qualification certificate. 30 Check the staff roster, personnel appointment documents, check the original academic certificates, title certificates, training certificates, on-site paper test or interview, 1 person can not meet the requirements of 5 points.
6 Enterprises should be engaged in quality management, product purchasing, quality acceptance, storage and custody, business sales and after-sales service positions such as personnel for the relevant laws and regulations, professional and technical, quality management and professional ethics and other knowledge training, training should be planned, documented and the establishment of training files. Veto Check the training program and files against the employee roster.
7 Enterprises should be set up with the scale of operations and business products to engage in technical training and after-sales service organizations or personnel, with the ability to provide appropriate technical training and after-sales service. Agreements agreed by the supplier or a third party to provide technical support, may not set up the relevant organizations and personnel.
To provide installation, maintenance, technical training and after-sales service for the customer's own enterprise, should obtain the authorization of the manufacturer, equipped with professionally qualified personnel, qualified by the supplier of professional training on duty.
Opening the second class of medical equipment business enterprises (instruments and equipment), engaged in installation, maintenance, technical training and after-sales service personnel, should have relevant professional secondary school education or above, or junior or above technical title;
Opening the third class of medical equipment business enterprises (instruments and equipment), engaged in installation, maintenance, technical training and after-sales service personnel, should have relevant professional college education or above, or intermediate or above technical title. Above education or intermediate or above technical title. 30 check the company set up institutions and personnel is reasonable; verify the relevant personnel academic certificates, title certificates original, check the technical service agreement and the original authorization and training (induction) certificate original. 1 person does not meet the requirements of the deduction of 5 points; did not set up institutions and personnel deduction of 20 points, is an agreement on the user (technical) services, did not sign a contract deduction of 20 points.
8 operation of medical materials, disposable sterile class and implantation, intervention and artificial organs class of medical devices, enterprises should be organized for quality management, product procurement, quality acceptance, storage and maintenance, sales and after-sales service and other direct contact with medical equipment products, personnel regularly (not less than 1 time per year) for health checks, provide health certificates and establish employee health records. Those who suffer from infectious or mental diseases are not allowed to work in direct contact with medical device products. 30 Verification of employee health records, 1 person did not physical examination deduct 10 points, less physical examination of 1 person / times deduct 5 points.
9 business implantation, intervention and artificial organ products enterprises should be equipped with qualified medical technicians or professionally trained personnel. Business fitting products should be equipped with at least one fitting physician or intermediate or senior workers or professionally trained and qualified fitting personnel. Sales staff should have high school education or above, familiar with product knowledge, and be able to skillfully answer relevant questions raised by users and customers. 30 Verification of education or qualification or title certificates, original training certificates, on-site questioning, 1 person who fails to meet the requirements will be deducted 5 points.
Items Terms Inspection Content Full marks Coefficient Score Inspection Method Deduction Reasons
Part II
Facilities and Equipment 10 The enterprise should have a relatively independent business premises compatible with the scale of operation and the scope of business. (1) Provincial municipalities within the area of comprehensive, professional agent of medical equipment business premises area (refers to the floor area, the same below) should be not less than 180 m2, 120m2. (2) county-level cities (including counties) below the comprehensive, professional agent of medical equipment business premises area should be not less than 150 m2, 100m2. (3) single-variety agent enterprise business premises area of not less than 60 m2. 60 m2. (4) business fitting products, provincial municipalities and county-level cities (including counties) below the business premises area should be not less than 50 m2, 30 m2, should be convenient for consumers to buy the front (store) room. Enterprise business premises shall not be located in residential type of housing, and meet the requirements of cleanliness, brightness, hygiene and so on. Negative Verify the scale and scope of business operations, on-site verification of the location of the business premises and property certificates or lease contracts (original), check the payment of housing rental fee receipts and the original housing lease certificate, if necessary, check the developer to hold the property's construction project planning license, check the company's indoor facilities.
11 The business (office) premises of the enterprise should be relatively centralized, separate from the living area, and set up with the organization of the enterprise in line with the identification of the door plate. Business premises should be bright, clean, hygienic, and set up product display room or product display cabinets. Display products should be placed in a reasonable, neat and orderly, can not be displayed should be hanging product pictures or product information. Business (office) premises should be equipped with appropriate office desks and chairs, fixed telephone, file cabinets, computers and other office equipment. Among them:
(1) part-time medical device products, enterprises should set up a special cabinet or business area, its product display and storage shall not be mixed with other products.
(2) the business of corneal contact lenses should be set up in a separate optometry room, the visual distance of 5 meters, or set up with a 2.5-meter reflector, with darkroom conditions and equipped with keratoconus curvature meter, intraocular pressure meter, corneal thickness meter, optometry, optometry box, slit lamps, farsightedness vision meter, examining glasses, fundus lenses and other instruments, there should be a clean and disinfected facilities.
(3) the business of hearing aids, the business premises should be set up with a reception room, examination room, hearing test room, etc., and have a good environment and health conditions. Should be equipped with hearing test instruments and equipment should at least include: audiometer, tuning fork, otological examination instruments and special equipment for hearing aid commissioning. 30 On-site verification, check the office space and door signs do not meet the requirements of each deducted 3 points; the lack of one of the necessary items deducted 5 points; one does not meet the requirements of the deduction of 3 points.
12 operation of disposable sterile class, medical materials and implantation, intervention and artificial organs class medical equipment enterprises should be equipped with its business scale appropriate computer equipment and management software, to ensure that the product from purchase to sale of the entire process of effective tracking and tracing. When the conditions are ripe, they can realize the computer data connection with the local food and drug regulatory departments, upload the relevant data of purchase, sale and storage in time, and have the conditions to accept the local food and drug regulatory departments to supervise their purchase, sale and storage through the remote monitoring platform. Negative Verification of the use of computer equipment and management software, management, etc., to check whether it can be reasonably used and realize the purchase, storage and sales of product quality management tracking and tracing.