Article I In order to strengthen the supervision and management of medical equipment business license, standardize the operation of medical equipment, according to "supervision and management of medical equipment regulations" and "medical equipment business license management approach" and other relevant provisions, combined with the actual province, specially formulated this acceptance standard.
The second this standard applies to the administrative region of Guangdong Province, Class Ⅱ, Ⅲ, "Medical Device Business Enterprise License" issued, reissued, changed, reissued applications.
The third business in vitro diagnostic reagents or the State Food and Drug Administration otherwise provided for medical devices, in accordance with its provisions.
Chapter II institutions and personnel
Article IV of the enterprise responsible for quality management should be familiar with the supervision and management of medical devices, rules and regulations, as well as food and drug supervision and management departments of the supervision and management of medical devices and the relevant provisions.
Article 5 The person in charge of the enterprise shall have college degree or above. Quality management shall have medical device related professional college degree or above and more than 1 year of relevant work experience, and effectively fulfill their job responsibilities. The person in charge of the enterprise and the quality management shall not be concurrent with each other.
Article VI of the enterprise organization is sound, should be set up with the scale and scope of operation of the quality management, acceptance, warehouse management, purchase and sale, after-sales service, computer management and other positions, and according to the job setup with medical equipment related professional and technical personnel with college education, the number of professional and technical personnel is not less than 8 people.
Article VII of the quality manager in the business process of the quality of medical devices have the right to rule. Operating more than 10 categories of enterprises should be set up, including the quality manager, not less than two full-time quality management organization.
Article VIII quality management personnel and professional and technical personnel shall be on duty, not part-time. Should sign a legal and effective labor contract with the company, with corporate personnel appointment letter.
Article IX the person in charge of the enterprise, the quality manager, the person in charge of sales and professional and technical personnel shall be qualified by training before taking up their duties. Enterprises should be regularly organized for the above personnel for medical device laws and regulations, regulations, professional knowledge, internal systems, professional ethics training or continuing education, and the establishment of relevant files.
Article 10 of the enterprise should be organized annually quality management personnel and professional and technical personnel to carry out health checks and establish files. Suffering from infectious diseases, skin diseases shall not be engaged in direct contact with medical devices.
Article XI of the enterprise computer management positions of professional and technical personnel, responsible for maintaining the enterprise's computer management information system and medical device business electronic regulatory information reporting.
Chapter III of the business and warehousing premises
Article XII of the registered address of the enterprise should be clear property rights. Its business premises should be equipped with well-functioning fixed telephone, fax machine, computer, network access devices, filing cabinets and other office equipment, a clean environment, the actual use of the area of not less than 80 square meters.
Article XIII of the enterprise should be in line with the scale and scope of business needs of the computer management information system, with a stable, secure network environment, the quality of medical devices, acceptance, storage management, purchase and sale, after-sales service, electronic regulatory information such as true, complete and accurate records and backup, with the implementation of food and drug supervision and management department of medical equipment business e-supervision. Supervision of the technical conditions.
Article XIV of the enterprise warehouse address should be clear property rights, non-residential use, relatively independent settings. Warehouse should be separated from the office living area, auxiliary operation area a certain distance or have isolation measures. Warehouse area should be ground level, doors and windows tight, clean and orderly, no water, no source of pollution. Shall not be used with the enterprise's non-medical device warehouse, medical device production warehouse (if any) ****.
Article XV of the warehouse should be equipped with facilities, equipment and devices that meet the requirements of the scale and scope of business and function well. Mainly include: light, ventilation, dust, moisture, insects, rodents, birds, pollution prevention equipment and devices; fire safety facilities; temperature and humidity monitoring and regulating equipment; lighting equipment in line with the requirements of safe electricity.
Article XVI in the library of medical equipment should be classified according to the batch of centralized stacking, spacing between the stacks; stacks and storage area of the ground, ceiling, walls, facilities, equipment and devices between the spacing or isolation measures. Uniform implementation of color-coded management: divided into areas to be inspected and return areas (yellow), qualified products and shipping areas (green), non-conforming products area (red). Corresponding position card records are true and complete traceability.
Article XVII has special storage requirements for medical devices, according to its product specification, the warehouse conditions should meet the business product storage requirements.
Chapter IV Quality Management System
Article 18 of the enterprise should be collected in a timely manner with the medical device business-related laws, regulations, rules and regulations and food and drug supervision and management departments of the supervision and management of medical devices related to the provisions of the dynamic management and establishment of files.
Article 19 of the enterprise to develop the medical device business quality management system should at least include:
(a) quality policy;
(b) quality responsibility;
(c) quality ruling process;
(d) quality information management;
(e) document management and control;
(f) departments and job responsibilities;
(vii) Training and assessment and continuing education;
(viii) First operator audit;
(ix) Supplier and purchaser audit;
(x) Purchase and sale of products;
(xi) Product acceptance, warehousing, and outgoing review;
(xii) Records and archives; tickets and vouchers;
< p>(xiii) non-conforming product control;(xiv) post-sale return product control;
(xv) quality tracking;
(xvi) quality incident handling;
(xvii) adverse event monitoring and management system for medical devices;
(xviii) medical device recall;
(xix) medical device management electronic Supervision and reporting;
(xx) computer information system maintenance and use;
(xxi) customer information feedback and processing;
(xxii) after-sales service and other content.
Article 20 of the enterprise should have a true and complete traceability of the purchase and acceptance records, must indicate the approved name of the medical device product, registration number, model, specification, production batch, sterilization batch (if any), packaging labels and specifications of the state of the manufacturer, supplier, purchase quantities, date of purchase, expiration date (if any) and so on, and contains product quality, acceptance of the conclusion of the acceptance of the acceptance of personnel Signature and other columns. Records should be consistent with the enterprise's computerized management information system electronic data.
Article 21 of the enterprise should have a true and complete traceability of the warehouse review and sales records, must indicate the approved name of the medical device product, registration number, model, specifications, production batch, sterilization batch (if any), packaging labels and instructions for the state of the manufacturer, buyer, shipping quantities, shipment date, expiration date (if any) and other content, and set out the quality of the status of the review, review the conclusion of the review, signed by the personnel, signed by the sales staff and other columns. Signature of the personnel, sales staff to sign the columns. Records should match the electronic data of the enterprise's computerized management information system.
Article 22 of the enterprise based on the systems and records developed by the relevant forms should at least include:
(a) organizational chart;
(b) personnel roster;
(c) personnel health checkups registration form;
(d) personnel training sign-in sheet;
(e) personnel assessment and continuing education form;< /p>
(f) Document use application form;
(g) Product quality information registration form;
(h) Qualification review form for the first enterprise;
(i) Supplier and purchaser qualification review form;
(j) Purchase of products acceptance form;
(k) Review of the products out of the warehouse and bill of sale;
(l) List of facilities and equipment;
(xii (X) facilities and equipment list;
(M) facilities and equipment use registration form;
(XIV) non-conforming products processing approval form;
(XV) after the sale of returned products registration and handling of the situation table;
(XVI) adverse event handling and reporting form;
(XVII) medical device recall record form;
(xviii) medical device business electronic monitoring report registration form;
(xix) customer information feedback form;
(xx) after-sales service record sheet.
Article 23 of the medical device business-related files established by the enterprise should at least include:
(a) human resources;
(b) personnel health checks;
(c) training and assessment and continuing education;
(d) suppliers and purchasers;
(e) first business;
(f) Product quality information;
(vii) purchase and acceptance records;
(viii) out of the warehouse review and sales records;
(ix) facilities and equipment;
(x) non-conforming products handling;
(xi) post-sale return of product management;
(xii) quality accidents;
(xiii) medical device adverse Events;
(xiv) medical device recall;
(xv) bills and vouchers;
(xvi) medical device business electronic monitoring report;
(xvii) customer information;
(xviii) after-sales service records and other content.
Chapter V Classification Management
Article 24 According to the State Food and Drug Administration in 2002 issued the "Classification of Medical Devices Catalog", in accordance with the risk and attributes of medical device products, in the operation of the business segment, will be divided into the following categories of medical device products management:
Class A (disposable aseptic and medical consumables class): 6815, 6863, Class II 6864, 6865 (except Class B), 6866.
Class B (implantation, intervention and other high-risk products class): Class III 6804, 6821-1, 6821-2, Class III 6821-3, Class III 6822 (except Class F), 6845, Class III 6846, Class III 6864, 6865-3, 6877.
Class C ( General medical equipment category): 6821 (except category B), Class II 6822, 6826, 6840, 6841, 6854, 6855, 6856, 6857, 6858.
Category D (large medical equipment category): 6823, 6824, 6825, 6828, 6830, 6831, 6832, 6833, 6870
Category E (fitting category): corneal contact lenses (soft, rigid, plastic corneal contact lenses) and their care fluids.
Class F (general medical devices): In addition to Class A-E, other Class II medical devices in the Classification Catalogue of Medical Devices (2002 edition) that require the application for a Medical Device Operator's License.
Article 25 of the business scope includes Class A medical devices, the actual use of the warehouse area should be not less than 200 square meters.
Article 26 of the business scope contains Class B medical devices, shall meet the following requirements:
(a) The person in charge of the enterprise shall have a bachelor's degree or above in a medical device-related field or a medical device-related professional title above the intermediate level.
(2) The quality manager shall have the following conditions:
1. bachelor's degree or above in clinical medicine or the title of attending physician or above;
2. more than 5 years of relevant work experience in medical institutions.
(3) should be in accordance with the requirements of the Guangdong Provincial Food and Drug Administration for medical device business electronic monitoring into the network, its computer management information system should be real-time, true, complete and accurate reporting of its operation of Class B medical device business information.
(d) If the manufacturer is a direct agent, it must obtain the authorization letter entrusted by the medical device manufacturer. If the manufacturer is not a direct agent, it must sign a quality agreement with the supplier to clarify the quality responsibility of both parties.
(E) to establish a risk management system, strengthen the quality tracking management system, quality accidents and adverse events management system, records and file management system, bills and vouchers management system, to ensure that after the listing of Class B medical devices can be traced, and to do a good job of collecting and analyzing the relevant adverse events.
Article 27 of the business scope contains Class C medical devices, shall meet the following requirements:
(1) the person in charge of the enterprise shall have a college degree or above in medical device related majors or intermediate or above title in medical device related majors;
(2) the quality manager shall have the following conditions:
1. a bachelor's degree in medical device related majors or Intermediate or above title in medical device related majors;
2. More than 2 years of medical device related work experience.
Article 28 of the scope of business contains Class D medical devices, with Class C requirements. The scope of business contains only Class D medical devices (franchise), may not set up warehouses, and other requirements with the C class.
Article 29 of the scope of business contains Class E medical devices, shall meet the following requirements:
(a) should be equipped with a junior optometrist above the title of professional and technical personnel;
(b) should be configured with a slit lamp microscope and other testing instruments.
Article 30 of the business scope contains one or more of categories B, C, E, F, the actual use of the warehouse area of not less than 40 square meters.
Chapter VI Supplementary Provisions
Article 31 of the standard from Article 4 to Article 23 of the general requirements, Chapter V, "Classification and Management" in the paragraphs for special requirements.
Check and acceptance, general and special requirements of the applicable provisions must be fully compliant. If there is more than one non-compliance, the acceptance is judged to be unqualified.
Article 32 of the nomenclature:
(A) medical device-related professions: machinery, engineering, electronics, medicine, pharmacy, nursing, biology, chemistry, testing, physics, computers, mathematics, materials, automation, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals, pharmaceuticals and information.
(2) Clinical medicine: clinical medicine (including medical specialties), Chinese medicine, integrated Chinese and Western medicine.
(C) the first enterprise: refers to the enterprise purchase of medical equipment, and its first supply and demand relationship with the medical equipment production or operation of enterprises.
Article 33 of the implementation of the provisions of this standard, "higher or lower" principle, for example:
At the same time the operation of Class A and B, the warehouse must be 200 square meters, the personnel must be B requirements, shall not be entrusted with the distribution.
At the same time the operation of C, D and not entrusted to the distribution, the warehouse needs 40 square meters.
At the same time all categories of business, the warehouse must be 200 square meters, personnel and equipment system must be B + E requirements, not entrusted distribution.
And so on.
Article 34 of these standards and Appendix A "above", including this number.
Article 35 of this standard since January 1, 2013 shall come into force, "Guangdong Province, the start of medical equipment business acceptance of the implementation of standards (2007 Revision)" since the date of implementation of this standard shall be repealed. Article 36 of this standard by the Guangdong Provincial Food and Drug Administration is responsible for interpretation.