Chapter I General provisions article, medical devices, in order to regulate the operation, use, strengthening the supervision and administration of medical devices operation, use, ensure the medical device is safe and effective, protection of human health and safety, in accordance with the regulation on supervision and administration of medical devices and the management of medical institutions and other relevant laws and regulations, combined with the city's actual, these measures are formulated.
Article in the administrative area of the city within the medical device business, use activities, supervision and management of the application of this approach.
Individual purchases for personal use medical devices Act exclude the application of this approach.
Third municipal food and drug supervision and management is responsible for supervision and administration of medical devices operating within the administrative area of the city and use of medical device quality and safety supervision and administration, guidance and supervision of food and drug supervision and Administration Department conduct supervision and management work, and organize the implementation of these measures.
Food and drug supervision and management is responsible for supervision and administration of medical devices operating within the area and use the link quality and safety supervision and administration of medical devices.
Health family planning administrative departments responsible within the statutory mandate of the medical institution, disease prevention and control institutions and family planning technical service institutions, blood banks, plasma stands and other medical devices used in the Apheresis units of supervision and administration of medical devices used.
Home, business, quality and technical supervision, business and other relevant administrative departments in their respective statutory mandates, to assist in the implementation of this approach. Fourth business and use of medical devices unit should ensure that operation, the use of the medical device is safe and effective.
Medical device distributing enterprise and use of the statutory representative, responsible person should ensure that the business enterprises and units operate in accordance with laws and regulations, the use of medical devices.
Centralized trading markets for medical device start-up, business manager shall strictly manage the admission management industry door, urging its legitimate business. Article fifth medical device distributing enterprise, and use shall organize and direct contact with medical personnel receive pre-service and annual health checks, setting up health records.
Suffering from diseases that may be contaminated medical instruments, may not engage in direct contact with the medical device, if found should be immediately removed from the post. Medical device distributing enterprise, use the unit should develop an annual training plan, pre-job training and continuing training for employed personnel, establish training records.
Training content should include the medical devices regulations, professional knowledge and skills, responsibilities and job procedures, quality management system, and so on.
Sixth article medical devices business enterprise, and using units purchased into medical devices Shi should perform following obligations, and retained related proved material: (a) determine supply units of legal qualification; (ii) determine supply units sales personnel of legal identity; (three) identification by procurement medical devices of registered card or record voucher; (four) obtained by supply units issued of legal notes; (five) and supply units signed including quality responsibility and after-sales service responsibility content of agreement; (six) legal regulations provides of other matters.
Chapter II management of medical devices article seventh class III medical device distributing Enterprise shall meet the requirements of quality control of medical devices information management system, ensure products can be traced back.
For other medical apparatus production enterprise to provide storage and distribution services for medical devices business, clients and should have real time electronic data interchange and implement whole process traceability information management platform product management and technical means.
Eighth article of any units and individuals engaged in the non-medical devices, on their labels or instructions shall not be marked with the intended purpose and classification of medical devices of the same, similar content.
Nineth medical device distributing company diversified into non-medical devices, must be separated from the exhibition, there are clear isolated and set a clear distinction between the marks.
Medical device distributing enterprise sales personnel must not confuse medical devices and non-medical products, and sale of medical products should take the initiative to inform consumers what to buy is a medical device. Tenth lecture, field experience selling to consumers in the form of medical equipment or similar intended purpose with the same medical device, product, event organizers should be informed of 7th District to the activity report of the food and drug administration time, location, and so on.
Activity organizers shall submit a related qualification certificates of the enterprises and products.
Received the report of the food and drug supervision and management departments should review the information if necessary, in conjunction with the industrial and commercial administrative departments to supervise and inspect the event found violations should be investigated in a timely manner.
11th medical equipment trade fairs, expositions, trade fairs and other activities of organized units should be a rigorous examination of admission to the production license, medical device registration or filing of documents, ensure that the admission of the legitimacy of companies, products, and early 10th district where the writing activities of the food and drug administration.
Exhibit is still in the research and development stage medical device, admission of enterprises should be clearly marked.
12th centralized trading markets for medical device start-up, business management should make the management industry door admission system, strengthening the management of admission management industry door, business owners on a regular basis undertake medical device regulatory laws and regulations information, and check the management industry door operation.
Run, managers found that business owners is illegal, should be promptly stopped, within 2 working days and to the report of the food and drug administration.
Run, managers shall, before December 31 of each year to the local food and drug supervision and management departments to submit an annual management report.
13th centralized trading markets for medical device start-up, Business Manager and admission to business operators shall cooperate with the food and Drug Administration inspection, investigation and other regulatory enforcement actions, not withholding the truth or being tipped off to the parties, shall not be under various pretexts refuse or obstruct the enforcement of administrative law-enforcement departments to check. Chapter III medical device management 14th units shall be equipped with its scale of management bodies or quality management.
Quality management in medical institutions at all levels institutions or the configuration requirements of quality management by the municipal public health family planning administrative departments together with the municipal food and drug supervision and management departments in accordance with national regulations.
Measurement management of medical institutions should be staffed with full-time or part-time staff, is responsible for managing the Agency's medical device measurement and shall apply to the quality and technology supervision departments periodic verification of measuring instruments.
15th medical devices use the unit should be managed by special departments or professional unified storage archiving of medical device inspection, testing, calibration, maintenance, maintenance and use of records as well as class III medical devices manuals, circuit diagrams, software, and maintenance of documents and other information.
Medical device inspection, testing, calibration, maintenance, maintenance and use of records should be archived in a timely manner, before the archive is used by Department for safekeeping.
Long term use of large medical equipment file that came with the device.
16th medical devices using units shall ensure that within the Department and medical devices adapted to the type, quantity and storage conditions and storage system, ensuring that departments within the medical devices subject to the provisions of conditions of storage, not easily approached by non-medical personnel.
Distribution of disinfection supply room disinfection of medical devices, medical devices use the unit should ensure that within the Department is equipped with a dedicated storage containers for storage, from pollution.
17th units implanted and intervention of medical devices class I medical devices, medical device name, key technical parameters should be closely related to using quality and safety information necessary for entry in the medical records, retained separately and included patients, doctors, medical equipment and the use of the content of records.
Operation have already been unpacked but not in use, could affect the quality and safety of implanted medical devices, medical devices and use should contact in accordance with the technical requirements for the production and operation, ensure that it is safe and effective.
18th medical apparatus using external experts shall not be used with implantable medical devices, used in implantable medical devices by using the unit should be purchased in accordance with regulations.
Article 19th medical device using units shall establish a scrapping system, expired, invalid, out, overhaul has failed to achieve safety standards for medical devices and not damaged, the packaging of disposable sterile medical devices, you should stop using and discard.
Supervision and administration of the fourth chapter 20th food and drug supervision and management departments should establish and medical equipment enterprises stipulated in this article seventh butt's electronic information system, and carry out real-time monitoring of the information input.
21st municipal food and drug supervision and management departments should be established for medical apparatus using position information system for assessment of professional knowledge and skills, for a medical device assessment service for enterprises, and use free.
22nd food and drug supervision and Administration Department shall, in conjunction with health and family planning, civil sector organizations such as medical device used to carry out adverse event surveillance and reporting. 23rd food and drug supervision and Administration Department shall, in conjunction with business, health and family planning sectors, such as medical apparatus, use administrative relative person of integrity management system.
Administrative relative person acts in violation of laws and regulations should be credited to the credit file.
According to the food and drug regulatory agency credit file assessment administrative relative person's credit rating, as the Chief law enforcement discretion, review considerations such as demonstration units. Have a bad credit history, should increase supervision and inspection, sampling frequency.
Serious breach of administrative relative person, his legal representative, officials should be included in the black list management. 24th medical equipment enterprises, units and centralized trading market there is a serious fake, adulterated, doped with impurities, a defective product and other violations, verified, the food and drug supervision and management departments should publicize a warning notice.
Notice period is 3 months.
25th article medical devices business enterprise, and using units has following case one of of, food drug supervision management sector can interviews its statutory representative people, and related head: (a) business, and using of medical devices for quality security problem was times reported, and complaints or media exposure of; (ii) occurred major quality security accident of; (three) exists serious illegal violations behavior of; (four) exists serious quality security hidden of; (five) credit grade evaluation for bad level of; (six) other need interviews of case. Interviews should rectify and implement action plan submitted to the food and drug administration after corrective action report.
Interviews refuses, the food and drug supervision and management departments should be disclosure to the community interviews.
Interview record credit files, and at the same time inform the relevant departments in charge of industry and industry associations.
Food and drug supervision and management departments should be interviewed as key regulatory objects for next year.
Article 26th on the labels and instructions for medical devices labeled forgery, fraudulent use of the certification mark, certification, by the quality and technical supervision Department is responsible for the investigation.
Food and Drug Administration found in medical device labels and instructions marked on forgery, fraudulent use of the certification mark, certification, quality and technical supervision departments should be informed in a timely manner. 27th the administrative supervision departments upon receipt of a complaint, report does not judge whether a product belongs to medical devices shall be to receive and investigate evidence; found in the inspection of law enforcement, investigation and evidence collection. Reception, investigation and evidence collection is unable to judge, and transferred at the food and Drug Administration determine whether the product is a medical device.
After the food and Drug Administration decision, refer to related administrative authorities in accordance with the nature of the product.
Non-medical device product labels and instructions marked on the intended purpose, structure, characteristics, methods of use and clear classification of medical devices of the same, similar, and in accordance with the definition of medical devices, by the food and drug supervision and administration in accordance with the unregistered or registered medical device processing.
28th within food and drug supervision and management is responsible for the administration of medical device advertising monitoring and found medical device advertising content in violation of should be escalation, and will be transferred to related materials and recommendations industrial and commercial administrative departments at the same level.
Food and drug supervision and management departments and industrial and commercial administration departments should establish communication and coordination mechanism and research illegal advertising of medical devices to investigate on a regular basis.
Article 29th of any unit or individual use medical device free diagnosis and treatment activities, was not present at the scene of medical institutions and medical personnel related qualification certificates, regulation by the health and family planning administrative departments.
Article 30th beauty salon operators are not part of the medical devices used by beauty salons equipment, equipment, the quality and technical supervision Department, administration for industry and Commerce according to regulation imposed on their production and business activities. 31st food and drug supervision and management departments should develop and implement annual monitoring sampling plan would oversee the sampling results escalation province food and drug administration.
Concentrated Exchange operating in the market of medical devices medical devices and medical devices used in medical devices should be classified as annual monitoring sampling objects.
Quality Bulletin issued by the food and drug supervision and management departments at all levels involved in the city of centralized trading market for medical devices by market area covered by the food and Drug Administration would be released in market.
Fifth chapter legal responsibility 32nd article medical devices business enterprise violation this approach Nineth article of provides, has following case one of of, by District food drug supervision management sector ordered corrected, at 2000 Yuan above 10,000 yuan following fine: (a) medical devices and non-medical devices products not separate displayed, and not for obviously isolation or not set obviously distinguish marked of; (ii) marketing Shi deliberately confusion products property of; (three) sales non-medical devices products Shi not active told consumers its by purchase of is medical devices products of.
33rd article violates the provisions of this article tenth, to lectures, field experience selling to consumers in the form of medical equipment or similar intended purpose with the same medical device, product, activity organizers of failing to report, by the food and Drug Administration ordered corrective action and fines of between 10,000 yuan and 30,000 yuan.
Article 34th medical equipment trade fairs, expositions, trade fairs and other activities organized in violation of the provisions of paragraph one of this article 11th, unapproved entry a production and operation license, registration certificate of medical devices or filing documents, or failing to report, by the food and Drug Administration ordered corrective action and penalty of between 50,000 yuan and 10,000 yuan.
Medical equipment trade fairs, expositions, trade fairs and other activities of the admission of enterprises that violate the provisions of the second paragraph of this article 11th, on-site exhibition is still in the development phase of the medical devices not specifically marked, by the food and Drug Administration ordered corrective action and penalty of between 50,000 yuan and 10,000 yuan.
35th article medical devices concentrated trading market of opened who, and business managers violation this approach 12th article of provides, has following case one of of, by District food drug supervision management sector ordered corrected, at 10,000 yuan above 50,000 yuan following fine: (a) not on admission business industry households for admission audit of; (ii) not on business industry households of business situation for check of; (three) found business industry households exists illegal business behavior, not stop or report of; (four) management not strict led to market within illegal situation serious of.
36th article medical devices concentrated trading market opened who, and business managers of following case belongs to this approach 35th article subsection (four) items provides of "market within illegal situation serious" case: (a) a years 5% above of business industry households was sentenced warning above of administrative punishment of; (ii) a years 3% above of business industry households was sentenced fine above of administrative punishment of.
37th medical apparatus used in violation of this article 17th paragraph, production and operation of enterprises not been contacted for surgery have been unpacked but not use, may influence the quality and safety of implantable medical device processing, by the food and Drug Administration ordered corrective action and more than 5000 Yuan and fined a maximum of 20,000 yuan.
Article 38th of medical devices used in violation of the provisions of article 18th, using external expert's of implantable medical devices, by the food and Drug Administration ordered corrective action and more than 5000 Yuan and fined a maximum of 20,000 yuan.
External experts in violation of the provisions of article 18th, using the implantable medical device from the food and Drug Administration warning and fined a maximum of between 1000 and 500 Yuan RMB.
39th medical apparatus used in violation of this approach the 19th article has not established a system of medical devices scrapped and scrapping system, by the food and Drug Administration ordered corrective action and penalty of between 5000 and 1000 Yuan.
40th district, particularly serious or especially serious cases on the merits, the municipal food and drug supervision and management departments in accordance with this approach.
41st food and pharmaceutical supervisory and administrative department in charge or relevant departments who abuses his power, favoritism and negligence, according to the circumstances, shall be subject to punishment constitutes a crime, criminal responsibility shall be investigated according to law.
Sixth chapter schedule 42nd article this approach by said of medical devices, is refers to directly or indirect for human of instrument, and equipment, and apparatus, and body outside diagnosis reagents and the calibration real, and material and other similar or related of items, including by need of computer software; its utility main through physical, way get, not through pharmacological learn, and Immunology or metabolism of way get, or although has these way participation but only up auxiliary role; its purpose is: (a) disease of diagnosis, and prevention, and guardianship, and treatment or ease;
(B) injury diagnosis, monitoring, treatment, alleviation of or compensation, and (iii) physiological structure or physiological process or inspection, replacement and adjustment support; (iv) life support or maintenance (e) pregnancy control (vi) through to examine samples from the body, for the purpose of medical or diagnostic information.
Non-medical devices in these measures refers to other products that do not meet the provisions of the preceding paragraph.
Management of medical devices referred to in this way, refers to the purchase and sale of medical devices in the form of products, including the procurement, inspection, storage, sale, transportation and after-sales service.
Use of medical devices in these measures refers to the use of medical equipment for the actions of others to provide medical services.
This approach by said of medical devices using units, is refers to using medical devices for others provides medical, technology service of institutions, including made medical institutions practice industry license of medical institutions, made family planning technology service institutions practice industry license of family planning technology service institutions, disease prevention control institutions, and law not need made medical institutions practice industry license of blood station, and single mining plasma station, and rehabilitation auxiliary apparatus suitable distribution institutions,. Centralized trading market of medical devices in these measures, is a start-up or management unified management, the provision of certain services, there are more fixed region-wide, centralized place for medical devices.
Whether medical devices focused on markets as well as region-wide centralized trading market of medical devices by the municipal food and drug supervision and administration authorities and the business sector, seat of the municipal administration of industry and commerce, the district people's Government. 43rd these measures come into force on June 1, 2016.