In vitro diagnostic reagents (medical devices) business acceptance criteria
Chapter I institutions and personnel
Article 1 In vitro diagnostic reagents (medical devices) business enterprise's legal representative or responsible person, quality management personnel, without the "supervision and management of medical devices" Article 40 of the Regulations.
The person in charge of the enterprise shall have college education or above, familiar with national laws, rules and regulations on the management of in vitro diagnostic reagents, and the knowledge of the in vitro diagnostic reagents operated.
The second shall have quality management personnel appropriate to the scale of operation, quality management personnel shall exercise quality management functions, the quality of diagnostic reagents have the right to rule. One of them is the supervisor of the examiner, or with a university degree or above in testing related disciplines and engaged in testing related work for more than 3 years of work experience.
Quality management personnel should be on duty, not part-time.
Article 3 acceptance, after-sales service personnel should have secondary school education in inspection; corporate custodianship, sales and other staff, should have a high school or secondary school education.
Article IV quality management, acceptance, custody, sales and other work positions, should receive induction training, pass the examination before taking up their posts.
Chapter II System and Management
Article 5 shall be based on medical device management laws and regulations and related documents to develop quality management documents in line with the actual enterprise, including quality management system, responsibilities, work procedures.
(1) The quality management system shall include: the management of quality management documents, the provisions of the internal review, the provisions of the quality veto, diagnostic reagents purchase, acceptance, storage, sales, warehousing, transportation, after-sales service management, diagnostic reagent expiration date of the management, the management of unqualified diagnostic reagents, the return of diagnostic reagents management, management of facilities and equipment, the management of personnel training, the management of the personnel's health status, the management of computer information management. management, computerized information management.
(2) Quality management responsibilities should include: quality management, purchase, acceptance, storage, sales, transportation, after-sales service, information technology and other job responsibilities.
(C) work procedures should include: procedures for quality management document management, diagnostic reagents purchase, acceptance, storage, sales, warehousing, transportation, after-sales service procedures, diagnostic reagents returned after the sale of the program, the confirmation of unqualified diagnostic reagents and processing procedures.
Article VI shall establish the purchase, acceptance, sales, warehousing, transportation and other content of the quality management records.
Chapter III Facilities and Equipment
Article VII shall have a bright and clean office and business premises, the area of which shall be appropriate to the scale of operation, but shall not be less than 100 square meters.
Article VIII should be set up in line with the requirements of diagnostic reagent storage warehouse, its area should be compatible with the scale of operation, but shall not be less than 60 square meters, and the environment of the warehouse area is clean and tidy, no source of contamination; diagnostic reagent storage and operation area should be effectively separated from the business, office and other areas; the warehouse walls, roofs, and floors should be clean and smooth, and doors and windows of the structure of the tightly closed.
Article IX Residential premises shall not be used as warehouses.
Article X shall be set up to store diagnostic reagents of cold storage, its volume should be compatible with the scale of operation, but shall not be less than 20 cubic meters. Cold storage shall be equipped with automatic monitoring, regulation, display, recording of temperature conditions and automatic alarm equipment, standby generator sets or installation of dual circuit, standby refrigeration units.
Article XI of the storage of diagnostic reagents in the warehouse shall have the following facilities and equipment:
(a) diagnostic reagents and the ground between the effective isolation of the equipment;
(b) ventilation and to avoid direct sunlight of the equipment;
(c) effective regulation, detection of temperature and humidity of the equipment;
(d) in line with the requirements of the storage operation of lighting equipment;
(e) the storage of reagents shall be equipped with automatic monitoring and control, display of temperature conditions and automatic alarm. p>
(v) unqualified diagnostic reagents, returned diagnostic reagents dedicated storage area or facilities and equipment;
(vi) packaging materials storage space and equipment;
(vii) diagnostic reagent quality status should be implemented color-coded management, to be determined diagnostic reagents for yellow, qualified diagnostic reagents for green, unqualified diagnostic reagents for red.
Article XII should be compatible with the scale of operation and business varieties, in line with the diagnostic reagent storage temperature and other characteristics of the transportation facilities and equipment.
Article XIII should have a computerized management information system to meet the diagnostic reagent management process and quality control requirements, and can be realized to accept the local food and drug supervision and management department supervision conditions.
Article XIV should be used to check the facilities and equipment, maintenance, calibration, repair, cleaning to establish a file.