Kunming City, medical device business supervision and management implementation rules (for trial implementation)
(Draft)
Chapter I General Provisions
Article 1 According to the "supervision and management of medical devices regulations" (State Council Decree No. 650), "supervision and management of medical devices business" (State Food and Drug Administration Decree No. 8),
The second in the administrative area of Kunming City, engaged in medical device business activities and their supervision and management, shall comply with these rules.
Article 3 According to the degree of risk of medical devices, medical devices business implementation of classification management. Management of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.
Article IV of the medical device business in accordance with the different sales targets are divided into wholesale, retail and wholesale and retail.
Wholesale of medical devices, refers to the sale of medical equipment to qualified business enterprises or the use of medical equipment business behavior.
Medical device retail, refers to the sale of medical devices directly to consumers of medical equipment business behavior.
Medical equipment wholesale and retail, refers to the enterprise both of the above two business practices.
Article 5 The medical equipment business enterprises engaged in retail business (including retail business of wholesale and retail enterprises) can only operate the medical equipment used by the consumers themselves, and the scope of business can be set with reference to the "Catalogue of Medical Devices Commonly Used by Families in Kunming (2015 Edition)", but it is not limited to the contents listed in the catalog.
Article 6 Enterprises operating medical device products that are otherwise regulated by the State Food and Drug Administration or the Yunnan Provincial Food and Drug Administration shall comply with its regulations.
Chapter II Business License and Record Management
Article 7 The Food and Drug Administration of Kunming City is responsible for the licensing of Class III medical device wholesalers and wholesalers and retailers in the main urban area (including the recording of the simultaneous operation of Class II medical devices), as well as the licensing and recording of the chain of stores for retailing some of the medical devices; the food and drug supervision and management departments of the main
urban districts In accordance with the Kunming Food and Drug Administration commissioned, is responsible for the administrative area only wholesale Class II medical devices for the record, as well as retail medical equipment retail stores and part of a single
chain store license and filing; outside the main city of the counties, districts Food and Drug Administration in accordance with the entrustment of the Food and Drug Administration of Kunming, is responsible for the administrative area of the medical device business enterprise License and record.
Article VIII of the county-level food and drug supervision and management department shall not be entrusted to other organizations or individuals to implement the medical device business license, filing.
Article IX engaged in the second, third class medical device business activities, in addition to the enterprise shall have to comply with the "supervision and management of medical devices business" set in Article VII of the conditions and the "quality management standard for the operation of medical devices" requirements, but also in accordance with the provisions of these rules. Whether the enterprise meets the filing and licensing conditions, by the city, county (district) levels of food and drug supervision and management departments on-site verification to determine.
Article X. Enterprises should be established with the scale and scope of operation of the organization, and clarify the management authority and responsibilities of each agency.
Article XI of the enterprise legal representative, responsible person, quality management personnel should be familiar with national and local laws and regulations on supervision and management of medical devices, regulations and norms and the operation of medical devices and related knowledge, and in accordance with relevant laws and regulations and the "Code for Quality Management of Medical Devices" stipulates that the qualification requirements, shall not be prohibited from practicing the relevant laws and regulations of the situation.
Article XII of the legal representative or person in charge of the enterprise is the main responsibility for the quality of medical device business, fully responsible for the day-to-day management of the enterprise shall provide the necessary conditions to ensure that the quality management organization or quality management personnel to effectively perform their duties, to ensure that the enterprise in accordance with the "quality management standard for the operation of medical devices" requirements for the operation of medical devices.
Article XIII of the enterprise shall have with the scale and scope of operation of the quality management organization or quality management personnel. Enterprise quality should be responsible for the independent performance of duties, within the enterprise on the quality management of medical devices have the right to rule, bear the corresponding quality management responsibility. The person in charge of enterprise quality shall not be the legal representative of the enterprise or the person in charge of the enterprise at the same time.
Article XIV of the enterprise quality management organization or quality management personnel shall perform the following duties:
(1) organization of the development of quality management system, guidance, supervision of the implementation of the system, and the implementation of the quality management system for inspection, correction and continuous improvement;
(2) responsible for the collection of laws, regulations and other relevant provisions related to the operation of medical devices. Implementation of dynamic management;
(c) supervise the relevant departments and positions to implement the medical device regulations and rules and this specification;
(d) is responsible for medical device suppliers, products, purchasers qualification audit;
(e) is responsible for the confirmation of unqualified medical devices, the process of unqualified medical devices to implement the supervision;
(f) is responsible for Medical device quality complaints and quality incident investigation, handling and reporting;
(vii) organization verification, calibration of relevant facilities and equipment;
(viii) organization of medical device adverse event collection and reporting;
(ix) responsible for the management of medical device recall;
(j) organization of the carrier entrusted with the transportation of the transport conditions and quality assurance capacity of the Audit;
(k) organization or assist in carrying out quality management training;
(l) other should be performed by the quality management body or quality management personnel duties.
Article XV of the medical device business enterprises responsible for quality and other quality management personnel shall be on duty, with nationally recognized relevant professional qualifications or titles, shall not be part-time in other units.
Article
Third class of medical devices business enterprises and the second class of medical devices wholesale enterprise quality officer should have medical device related professional (medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy,
nursing, rehabilitation, testing, management, computers and other professions) college degree or above, or more than intermediate professional and technical titles, and should have three years of relevant professional qualifications or titles, and at the same time should have three years of relevant professional qualifications or titles. Technical title, and should have more than 3 years of medical device quality management experience.
Article XVI of the enterprise shall be set up or equipped with business scope and scale of operation, and meet the relevant qualification requirements of the quality management, business and other key positions.
(a) engaged in the wholesale business of in vitro diagnostic reagents quality management personnel, there should be a supervisor of the inspector, or with a university degree in testing related disciplines and engaged in testing related work for more than 3 years of work experience. In vitro diagnostic reagents engaged in acceptance and after-sales service work, should have a secondary school education in laboratory science or related disciplines, or with a junior or above the professional and technical title of inspector.
(B) engaged in implantable and interventional medical devices business personnel should be equipped with medical related college degree or above, and through the production enterprises or suppliers of training personnel.
(C) engaged in corneal contact lenses, hearing aids and other medical devices that require fitting business personnel should be equipped with relevant professional or vocational qualifications.
(D) engaged in other special requirements of medical devices business personnel should be equipped with relevant professional or vocational qualifications.
Article XVII of the acceptance, after-sales service, warehouse storage, sales and other personnel should have secondary school (high school) or above, and after the medical device laws and regulations and professional knowledge of the induction training, after-sales service personnel should be through the production enterprise or other third-party technical training and obtain the enterprise after-sales service license.
Article XVIII of the enterprise shall carry out health management of employees, the establishment of employee health records, quality management, acceptance, warehouse management and other direct contact with medical equipment positions, should be at least once a year for a health check. Physical conditions do not meet the specific requirements of the corresponding positions, shall not engage in related work.
Article 19 Enterprises shall, in accordance with the supervision and management of medical devices regulations, rules and regulations and relevant provisions of the development of enterprises in line with the actual situation, covering the whole process of medical device quality management system, and save the relevant records or files, including the following:
(a) the quality management organization or the quality of management personnel's responsibilities;
(b) the provisions of the quality management;
(c) the quality management of the provisions;<
(C) procurement, receipt, acceptance of the provisions of the acceptance (including procurement records, acceptance records, accompanied by a list of goods, etc.);
(D) supplier qualification audit of the provisions of the audit (including suppliers and product legality audit of the relevant documents, etc.);
(E) warehouse storage, storage management provisions (including temperature records, records of warehousing, records of periodic inspections, records of storage);
(F) storage, storage management provisions (including temperature records, records of warehousing, records of periodic inspections, records of storage). Records, etc.);
(F) sales and after-sales service provisions (including salesperson authorization, purchaser files, sales records, etc.);
(G) the management of unqualified medical devices (including records of destruction, etc.);
(H) the provisions of the return and replacement of medical devices;
(I) the provisions of the monitoring and reporting of adverse events of medical devices (including stopping the operation and notification records, etc.). (including the cessation of business and notification records, etc.);
(j) medical device recall provisions (including medical device recall records, etc.);
(k) facilities and equipment maintenance and verification and calibration provisions (including facilities and equipment related records and files, etc.);
(l) health and personnel health status provisions (including employee health records, etc.);
(XIII) quality management training and assessment provisions (including training records, etc.);
(XIV) medical device quality complaints, accident investigation and handling of reports (including quality complaints, accident investigation and handling of reports of the corresponding records and files, etc.);
Enterprises engaged in the wholesale business of the second class, third class medical devices should also be developed to qualify for the purchase of the buyer audit, Medical device tracking and tracing, quality management system to implement the provisions of the assessment. Enterprises engaged in the retail business of Class III medical devices should also establish the buyer's information registration requirements to ensure that sales information can be traced.
The third class of medical devices business enterprises should establish quality management self-examination system, at the end of each year to the food and drug supervision and management department responsible for routine supervision and inspection of the annual self-examination report.
Article 20 Enterprises
Enterprises should be based on the scope of business and scale of operation to establish and implement the appropriate quality management record system, including purchase inspection and sales records and other systems. Incoming inspection records (including procurement records, acceptance records) and sales records information
should be true, accurate and complete. Incoming inspection records and sales records should be saved to the expiration date of medical devices after 2 years; no expiration date, not less than 5 years. Implantable medical devices purchase inspection records and sales records should be kept forever
long.
Enterprises engaged in the wholesale business of medical devices, its purchase, storage, sales and other records should meet the requirements of traceability. Encourage enterprises to use information technology and other advanced technological means of recording.
Article 21 The enterprise shall have with the operation of medical equipment products appropriate technical training and after-sales service capacity, or agreed by the state-recognized third-party institutions or the authorized operation of the manufacturer (including the import of the general agent) to provide technical support, and effectively carry out their work.
Article 22 of the enterprise shall have with the scale and scope of operation of the business premises and warehouses. Business premises and warehouses shall not be located in residential areas, military management areas (excluding leasable areas) and other places unsuitable for business, provincial and municipal people's governments on the business premises of the enterprise otherwise provided for, in accordance with its provisions. The business premises shall be clean and hygienic, and shall not be used as a living area.
Article 23 in the administrative area of Kunming City, engaged in the wholesale of medical equipment business enterprises, business premises and warehouses shall not be separated from the main urban area and the main urban areas outside the administrative area, the business premises and warehouses shall not be more than the setting of more than 2 addresses.
Article 24 of the business premises should be equipped with fixed telephone, computer, printer, office desk and chair, filing cabinets and other necessary office equipment, medical equipment wholesale business premises area of not less than 100 square meters.
Article 25 of the medical device retail business premises should be compatible with its business scope and scale of operation, and meet the following requirements:
(a) equipped with display shelves and counters;
(b) the relevant license hanging in a conspicuous position;
(c) the publication of food and drug supervision and management supervision and management of supervision and management department of the telephone number, set up the customer's opinion book;
(d) the business premises should be equipped with fixed telephone, computer, printer, office desk and chair, filing cabinets and other necessary office equipment. /p>
(D) the operation of medical devices require refrigeration, freezing, should be equipped with temperature monitoring, display of cold cabinets;
(E) the operation of detachable medical devices, should be equipped with medical devices, detachable sales of tools, packaging supplies, detachable medical device labeling and instructions should be consistent with the relevant provisions.
Article 26 of the retail medical device display shall meet the following requirements:
(1) according to the classification and storage requirements of the partition display, and set up conspicuous signs, category labels in clear writing, placed accurately;
(2) medical devices should be arranged in a neat and orderly manner, to avoid direct sunlight;
(3) the need for refrigeration, freezing of medical equipment Placed in the refrigeration, freezing equipment, the temperature should be monitored and recorded;
(D) medical devices and non-medical devices should be displayed separately, there is a clear separation, and conspicuous signs.
Article 27 is engaged in fitting medical devices retail business, the premises should also meet at least the following requirements:
(a) should be in the business premises in a conspicuous position to publicize the fitting procedures, fitting personnel qualifications, health management system and other content.
(B) operating Ⅲ-6822 medical optical instruments, instruments and endoscopic equipment (corneal contact lenses), the premises should be set up to check the optometry room, fitting table, hand washing device, hand dryer, etc., equipped with visual acuity meter, slit lamp, computerized optometry, vision lens box (instrument), corneal curvature meter, focus meter, pupil gauge and other eye examination, measurement facilities and equipment.
(C) business II-6846 implantable materials and artificial organs (hearing aids), the premises should have hearing aids and related facilities and equipment required for testing and dispensing, there should be compliant with the requirements of the audiometric room, audiometer, fitting room, effect assessment room, computer and so on.
Article 28 of the medical device warehouse site selection, design, layout, construction, renovation and maintenance should be in line with the requirements of medical device storage, to prevent confusion, error or defacement of medical devices, and with the characteristics of the medical device product requirements of the storage facilities, equipment. Should be in a conspicuous position should be posted medical equipment acceptance, warehousing, storage, warehousing and return system, regulations or procedures.
Article 29 The library of medical devices and non-medical devices should be stored separately, and have a clear separation and conspicuous signs. Medical device storage operation area, auxiliary operation area should be separated from the office and living areas a certain distance or physical isolation measures, and shall not be stored with the storage management of unrelated items. Drug companies operating medical devices, should set up a special area or special library for medical devices.
Medical device products should be classified, stored in batches, should be taken according to the quality of the state control measures, the implementation of zone management, and the use of color coding to distinguish between zones and color coding settings include: to be inspected area (yellow), qualified area (green), unqualified area (red), the return area (yellow), the delivery area (green). Implantable interventional products should be set up special areas or counters, returned products should be stored separately.
Article 30 The conditions of the warehouse shall meet the following requirements:
(1) the warehouse inside and outside the environment is clean and tidy, no source of pollution;
(2) the interior walls of the warehouse is clean and smooth, the ground is flat, the housing structure is tight;
(3) there are preventing the outdoor loading and unloading, handling, receiving, shipping and other operations affected by the abnormal weather measures;
(4) the warehouse There are reliable security measures to enable controlled management of the entry of unrelated personnel.
Article 31 The warehouse shall be equipped with facilities and equipment appropriate to the scope of business and scale of operation, including:
(a) effective isolation between medical devices and the ground, including shelves, mats or trays;
(b) light, ventilation, dust, moisture, water, fire, insects, rodents, pollution prevention facilities;
(c) Lighting equipment in line with the requirements of safe electricity;
(d) the storage of packaging materials;
(e) special requirements of medical devices should be equipped with the appropriate facilities and equipment.
Article 32 of the warehouse temperature, humidity should be consistent with the operation of medical equipment instructions or labeling requirements. Special temperature and humidity storage requirements of medical devices, should be equipped with effective control and monitoring of temperature and humidity equipment or instruments.
Article 33 of the wholesale need for refrigeration, freezing storage and transportation of medical devices, should be equipped with the following facilities and equipment:
(a) the scale of its business and business varieties of cold storage;
(b) used for cold storage temperature monitoring, display, record keeping, control, alarm equipment;
(c) to ensure that the refrigeration equipment for normal operation of the facility (such as) Standby generator sets or double circuit power supply system);
(d) enterprises should be equipped with refrigerated trucks, warming trucks, or refrigerated boxes, warming boxes and other equipment according to the corresponding scale of transportation and transport environmental requirements;
(e) special temperature requirements for medical devices, should be equipped with facilities and equipment to meet its storage requirements.
Article 34 According to the "Classification of Medical Devices Catalog" and the storage characteristics of medical devices, engaged in the second and third class of medical devices wholesale business, the storage area shall meet the following conditions:
(a) business class code for Class III, Class II 6840 clinical test and analysis instruments and diagnostic reagents (including diagnostic reagents), the storage area shall not be less than 60 square meters, the cold storage volume shall not be less than 20 square meters. Cold storage volume shall not be less than 20 cubic meters.
(B) business class code for Ⅲ-6821 medical electronic instruments and equipment, Ⅲ-6822 medical optics, instruments and endoscopic equipment, Ⅲ-6846 implantable materials and artificial organs, Ⅲ-6845 extracorporeal circulation and blood processing equipment, Ⅲ-6877 interventional equipment products, warehouse area of not less than 50 square meters.
(C) business class code for Ⅲ-6815 injection and puncture instruments, Ⅲ-6863 stomatology materials, Ⅲ-6864 medical hygiene materials and dressings, Ⅲ-6865 medical suture materials and adhesives, Ⅲ-6866 medical polymer materials and products, warehouse area of not less than 150 square meters.
(D) the operation of the above class code other than Class Ⅲ medical devices, warehouse area of not less than 30 square meters.
(E) only engaged in Class II medical devices (excluding in vitro diagnostic reagents) wholesale business, should be compatible with the scale and scope of business, the warehouse area is not a specific requirement, the warehouse should be able to meet the needs of zoning and color-coded management, set up in line with the requirements of the storage characteristics of the medical device facilities and equipment.
At the same time the operation of the above categories of products, warehouse area and conditions according to the above categories for the cumulative.
Article 35 If there is one of the following business behaviors, the enterprise can not set up a separate medical device warehouse:
(1) only operating the single drug retail enterprises and medical device retail stores of the varieties listed in the Catalogue of Medical Devices Commonly Used in Kunming Families (2015 Edition), and the display conditions of the business premises can meet the product display needs and quality management requirements;
(ii) chain retail stores (pharmacies) operating only the varieties listed in the "Kunming Catalog of Medical Devices Commonly Used in the Home" (2015 edition);
(iii) all entrusted to provide storage and distribution services for other medical device manufacturers and operators of medical equipment business enterprises for storage;
(iv) operating only the software for medical devices or medical magnetic **** vibration, medical X-ray, medical high-energy rays, medical nuclide equipment and other large medical equipment;
(E) national and provincial food and drug supervision and management departments of the provisions of the other can not be set up separately in the case of medical equipment storage.
Article 36 of the third class of medical devices business enterprises, should have a medical device business quality management requirements of the computer information management system to ensure that the operation of the product can be traced. Computer information management system shall have the following functions:
(a) with the realization of interdepartmental, between the position of information transfer and data **** enjoy the function;
(b) with the medical device business ticket generation, printing and management functions;
(c) with a record of medical device product information (name, registration certificate number or record certificate number, Specification model, production lot number or serial number, production date or expiration date) and production company information and to achieve quality traceability tracking function;
(d) including purchasing, receiving, inspection, storage, inspection, sales, warehousing, review and other aspects of the business process of the quality control function, can be judged, control the business process, to ensure that all the quality control function of real-time and effective;
(E) with suppliers, purchasers and the purchase and sale of medical devices, the legitimacy and validity of the audit and control functions;
(F) with the expiration date of the inventory of medical devices for automatic tracking and control functions, near-expiration warning and over the validity of the automatic locking and other functions, to prevent the expiration date of the sale of medical devices.
Encourage the operation of the second class of medical devices business enterprises to establish a computerized information management system in line with the quality management requirements of medical device business.
Article 37 of the enterprise for other medical equipment production and management enterprises to provide storage, distribution services, should meet the "Medical Device Business Quality Management Standard" Article 31, "Yunnan Province, medical equipment storage and distribution of enterprise standards" and Kunming on the medical device storage and distribution of the relevant requirements of the activities.
Chapter III Supervision and Inspection
Article 38
Kunming Food and Drug Administration and the county (district) level food and drug supervision and management departments shall, in accordance with the terms of reference or division of responsibilities and the requirements of the work responsibility objectives, regularly or irregularly on the medical device business in the administrative area
Enterprises in line with the requirements of the Code of Practice for the Management of Business Quality Supervision and inspection, urging enterprises to standardize business activities. Class III medical device business enterprises in accordance with the requirements of the quality management standard for the operation of medical devices to carry out a full program of self-inspection of the annual
degree self-inspection report should be reviewed, if necessary, to carry out on-site verification.
Article 39 Kunming Food and Drug Administration in accordance with the provincial bureau of the annual daily supervision and inspection plan to develop the city's medical device business enterprises regulatory focus, inspection frequency and coverage, and organization and implementation. The food and drug supervision and management departments of the counties, development (resort) parks are responsible for the development and organization of the annual daily supervision and inspection plan in their respective jurisdictions.
Article 40 In one of the following cases, the food and drug supervision and management department shall strengthen the on-site inspection:
(1) There are serious problems in the previous annual supervision and inspection;
(2) Those who have been subjected to administrative penalties due to violation of the relevant laws and regulations;
(3) Newly opened Class III medical device business enterprises;
(4) Through the review of annual reports found that there is a quality risk of business enterprises;
(e) food and drug supervision and management department that need to carry out on-site inspection of other circumstances.
Article 41
The food and drug supervision and management department in the daily supervision and inspection of the enterprise, found that the enterprise does not have the original operating license conditions or inconsistent with the filing information, can contact with the enterprise, may be in accordance with the "Yunnan Province medical device production and operation and use of
Interview system (for trial implementation)" to the enterprise for interviews, after the interview, the enterprise still does not correct Violations of the law, should be in accordance with the "supervision and management of medical devices" relevant provisions of the penalties; unable to contact with the enterprise
industry, the original license or record department in its government website on the enterprise information to be publicized, within one month from the date of publication, the enterprise has not been to the licensing or filing department for the relevant formalities or to make a statement, the original licensing or preparation
case department Cancellation of its medical device license or in the second class of medical equipment business filing information to be marked and announced to the community.
Article 42 The food and drug supervision and management department shall establish a medical device business supervision file, record licensing and filing information, the results of routine supervision and inspection, investigation and handling of violations and other circumstances, and have a poor credit record of medical equipment business enterprises to implement key supervision.
Chapter IV Supplementary Provisions
Article 43 The main urban areas in these rules refers to the Wuhua District, Panlong District, Guandu District, Xishan District, Chenggong District, High-tech Industrial Development Zone, Economic and Technological Development Zone, Dianchi Tourism Resort eight administrative areas.
Article 44
Food and drug supervision and management departments in the licensing and filing of on-site verification, the legal representative of the enterprise, the person in charge of the enterprise and the person in charge of quality should be present to assist and accept the assessment, the legal representative of the enterprise is unable to be present, should be submitted to the authorization
Authority to power of attorney. The inspectors determine the reasonable lack of items according to the business mode, business model and the scope of business applied for, and verify the applicable items one by one, and if all of them are in line, assessed as qualified; if any item is not qualified, judged
as unqualified; if rectification is required within a certain period of time, the enterprise shall complete the rectification in the stipulated period of time.
Article 45 Before the implementation of these rules has been obtained "medical device business (enterprise) license" or has been filed for the record of the enterprise, should be in the license change and continuation as well as filing credentials for the change to meet the "quality management standard for the operation of medical devices" and the requirements of these rules.
Article 46 These Rules shall come into force on XX/XX/2015. If national and local laws and regulations require otherwise or there are subsequent provisions, the provisions shall apply.