Order of the State Council of the People's Republic of China
Number 680th
The decision of the State Council on Amending the regulations on the supervision and administration of medical devices is hereby promulgated and shall come into force as of the date of promulgation.
Prime Minister Li Keqiang
May 4, 2017
Decision of the State Council on Amending the regulations on the supervision and administration of medical devices
The State Council has decided to make the following modifications to the regulations on the supervision and administration of medical devices:
First, the eighteenth amended as: medical equipment to carry out clinical trials, clinical trials of medical devices shall be in accordance with the norms of quality management requirements in clinical trial institutions have the appropriate conditions, and proposed the relevant province, autonomous regions and municipalities directly under the people's government food and drug supervision and management departments for the record to clinical trials. The food and drug administration department that accepts the clinical trial record shall notify the competent departments of food and Drug Administration and the competent departments of health and family planning at the same level where the clinical testing institution is located.
"Medical device clinical trial institutions" for the record management. Clinical trials of medical institutions should have the conditions and record management and quality of clinical trial management practices, by the State Food and drug administration under the State Council and the health planning departments to develop and publish."
Two, the first paragraph of the thirty-fourth, second merger, as the first paragraph: "medical device use units should have and in the use of medical equipment varieties, the number of storage places and conditions.". Medical device users shall strengthen technical training for their staff and use medical instruments in accordance with product specifications, technical operation specifications and so on."
One paragraph is added as the second paragraph: "the use of medical devices unit configuration of large medical equipment, large medical equipment configuration planning should be in line with the state health departments to develop, and its function, adapt to demands of clinical service, professional and technical personnel with technical conditions and corresponding facilities and have the corresponding qualifications, ability, and the people's governments at or above the provincial level health planning departments for approval, obtain configuration permits large medical equipment."
One paragraph shall be added as the third paragraph: "the measures for the administration of the allocation of large medical equipment shall be formulated by the competent department of health and family planning under the State Council in conjunction with the relevant departments under the State Council.". The catalogue of large medical equipment shall be submitted by the competent department of health and family planning of the State Council to the relevant departments under the State Council and submitted to the State Council for approval before implementation."
Three, fifty-sixth will be the first and the second paragraphs of the merger, as the first paragraph: "food and drug supervision and management departments should strengthen the production of medical equipment, the production and operation of enterprises and business units, the use of medical equipment inspection. No inspection fees or any other fees shall be collected for spot checks, and the necessary expenses shall be included in the budget of the government at the corresponding level. The food and Drug Administration of the people's governments at or above the provincial level shall publish the quality control of medical devices in a timely manner in accordance with the conclusion of random inspection."
One paragraph is added as the second paragraph: "the health planning departments should be on the use of large medical equipment status monitoring and evaluation; found illegal use and excessive examination, and large medical equipment over treatment and other circumstances, should be corrected immediately, shall be handled according to law."
A four increase, sixty-third, as the third paragraph: "the unauthorized use of the configuration of large medical equipment, by the people's governments at or above the county level health administrative department shall be ordered to stop the use, give a warning, confiscate the illegal income; the illegal income is less than 10 thousand yuan, and a fine of 10 thousand yuan and 50 thousand yuan of illegal income; more than 10 thousand yuan, more than 5 times the illegal income and impose a fine of 10 times; if the circumstances are serious, large medical equipment configuration permits the responsible person and the unit will not be accepted within 5 years."
Five, the sixty-fourth paragraph is amended as: "to provide false information or by other fraudulent means to obtain medical device registration certificate, production license, medical device license, medical equipment, large medical equipment configuration permits advertising approval documents of license, license revoked by the original issuing department has been fined, impose a fine of 50 thousand yuan and 100 thousand yuan, medical licensing unit responsible person and the application will not be accepted within 5 years."
A six increase, sixty-sixth, as the second paragraph: "enterprises, units of medical equipment business to fulfill the provisions of this Ordinance, purchase inspection and other obligations, there is sufficient evidence to prove that it does not know the medical instruments management and use of the first and third provisions of medical cases, and truthfully reveals the the source may be exempted from punishment, but shall confiscate the management and use of medical devices do not meet the statutory requirements."
Seven, sixty-eighth increase of one item, as the ninth item: "(nine) medical device use units in violation of large-scale medical equipment, medical quality and safety can not be guaranteed", and the original ninth to tenth.
Eight, the sixty-ninth amended as: in violation of the regulations of medical devices to carry out clinical trials by the people's government at or above the county level, food and drug supervision and administration department shall order rectification or stop clinical trials, may be fined 50 thousand yuan; causing serious consequences, demotion, dismissal or expulsion of the directly responsible personnel in charge and other directly responsible personnel in accordance with the law; the organization within 5 years shall not carry out related clinical trials of medical devices.
"Clinical trials of medical institutions issued a false report by the people's government at or above the county level, food and drug supervision and administration department for more than 50 thousand yuan to 100 thousand yuan fine; the illegal gains, confiscate the illegal income; the directly responsible personnel in charge and other persons directly responsible for dismissal or expulsion according to law; the agency within 10 years not to carry out related clinical trials of medical devices."
Nine, the seventy-third amended as: "health food and drug supervision and management departments, planning departments and their staff shall be strictly in accordance with the regulations of the punishment of the type and magnitude according to the nature of illegal behavior and the specific circumstances of the exercise of administrative punishment, specific measures for planning departments according to their respective duties shall be formulated by the health food and drug supervision and management departments of the State Council."
Ten, seventy-sixth increase provision: "large medical equipment" refers to the use of complex technology, large amount of capital input, high operating costs, medical expenses, and into the directory management of large medical equipment."
This decision shall come into force as of the date of promulgation.
The regulations on the supervision and administration of medical devices shall be revised accordingly and promulgated in accordance with this decision.
Regulations on the supervision and administration of medical devices
(State Council Decree No. 276th of January 4, 2000 People's Republic of China announced in February 12, 2014 thirty-ninth executive meeting of the State Council revised by May 4, 2017 according to the "State Council on Revising the" medical equipment supervision and management regulations "decision Revision)
Chapter I General Provisions
Article 1 These Regulations are formulated for the purpose of ensuring the safety and effectiveness of medical devices and safeguarding the health and safety of human beings.
Article second these Regulations shall be observed in the development, production, operation and use of medical instruments within the territory of the People's Republic of China and their supervision and administration.
Article third food and drug administration under the State Council is responsible for the supervision and management of medical equipment throughout the country. The relevant departments under the State Council shall be responsible for the supervision and administration of medical devices within their respective functions and responsibilities.
The food and drug administration departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective functions and responsibilities.
The food and drug administration under the State Council shall, in conjunction with the relevant departments under the State Council, implement the plans and policies of the state medical equipment industry.
Fourth countries classified management of medical devices according to the degree of risk.
The first kind is the low risk, the routine management can guarantee its safe, effective medical instrument.
The second category is a moderate risk, the need to strictly control the management to ensure its safe, effective medical equipment.
The third category is high risk, special measures should be taken to strictly control the management to ensure the safety and effectiveness of medical devices.
To assess the risk level of medical devices, the expected purpose, structural features and methods of use of medical devices should be considered.
The classification rules of food and drug supervision and Administration Department of the State Council is responsible for the development of medical devices and categories, and according to the production of medical equipment, management and use of medical devices, timely change of risk analysis and evaluation, to adjust the catalogue. In formulating and adjusting classified catalogues, the opinions of the enterprises engaged in the production and operation of medical devices and the units and trade organizations concerned shall be fully taken into account, and the practice of international classification of medical devices shall be referred to. The classified catalogue of medical devices shall be published to the public.
The development of fifth medical devices should follow the principles of safety, effectiveness and economy. The State encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the popularization and application of new medical device technology, and promotes the development of medical device industry.
Sixth medical device products should meet the mandatory national standards for medical equipment; there is no mandatory national standards should be in line with the mandatory medical equipment industry standards.
The catalogue of disposable medical instruments shall be formulated, adjusted and promulgated by the food and drug administration under the State Council in conjunction with the competent department of health and family planning under the state council. Repeated use can guarantee safe and effective medical instruments, not included in the catalogue of medical instruments for single use. Because of the repeated use of the design, production process, disinfection and sterilization technology, it can guarantee the safety and effectiveness of medical instruments, and shall adjust the catalogue of medical instruments for one use.
Seventh medical equipment industry organizations should strengthen industry self-regulation, and promote the construction of good faith system, and urge enterprises to carry out production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.
The second chapter: registration and filing of medical device products
Eighth, the first type of medical equipment products management for the record, second categories and third types of medical devices, product registration management.
Article ninth the first category of medical device products for the record and apply for second categories and third types of medical device products registration, should submit the following information:
(1) product risk analysis data;
(two) product technical requirements;
(three) product inspection report;
(four) clinical evaluation data;
(five) product specification and sample label;
(six) quality management system documents related to product development and production;
(seven) other information needed to prove the safety and effectiveness of the product.
The medical equipment registration applicant and the record holder shall be responsible for the authenticity of the submitted data.
Tenth products of the first category of medical equipment for the record, from the record holder to the location of the city's district government food and drug administration to submit information for the record. The product test report can be self inspection report for the record of people; clinical evaluation data does not include clinical trial report, can be through the literature, the clinical use of similar products obtained data show that the safety and effectiveness of a medical device data.
The first class of medical equipment exports to China in the overseas production enterprises, by the representative offices established in China or designated within the territory of China enterprise legal person as an agent, and record data submitted for the record to the State Food and Drug Administration in the country (region) authorities allowed the medical equipment listed in the sales documents.
Any change in the matters specified in the archival filing materials shall be subject to change to the original archival filing department.
Article eleventh for the registration of second types of medical device products, the applicant shall submit registration application materials to the food and Drug Administration Department of the people's Government of the province, autonomous region or municipality directly under the central government in the locality where it is located. In applying for registration of third types of medical device products, the applicant for registration shall submit the application materials to the food and drug administration department under the state council.
To exit second, China's third types of medical equipment overseas production enterprises, shall be made by the representative offices established in China or designated within the territory of China enterprise legal person as an agent, submit registration information and registration of the applicant to the State Food and Drug Administration (regions) to permit the medical department instruments listed in the sales documents.
The second class, third class medical device product registration information in the inspection report shall be issued the inspection report of medical inspection agencies; clinical evaluation data should include clinical trial report, but in accordance with the regulations of article seventeenth except from medical devices for clinical trials.
Twelfth food and drug administration departments that accept the registration application shall transfer the registration application data to the technical review institution within 3 workdays from the date of acceptance. The technical review institution shall submit a review opinion to the food and drug administration after the completion of the technical review.
Thirteenth food and drug administration departments that accept registration applications shall make a decision within 20 workdays from the date of receipt of the review opinions. Those who meet the requirements for safety and effectiveness shall be allowed to register and issued a medical device registration certificate; if they do not meet the requirements, they shall not be registered and shall give reasons in writing.
The food and drug supervision and Administration Department of the State Council in the organization of the technical review of the imported medical instruments that the necessary verification of the quality management system, shall organize the examination of the quality management system and technology institutions to carry out quality management system verification.
Fourteenth registered second types, third types of medical equipment products, substantial changes in its design, raw materials, production process, scope of application, the use of such methods, influence the safety and effectiveness of a medical device may, the registrant shall apply to the original registration department to apply for alteration registration procedures; non substantive changes. Do not affect the safety and effectiveness of a medical device, shall record changes to the original registration department.
Fifteenth medical device registration certificate valid for 5 years. Where a registration is required at the expiration of the term of validity, the application shall be submitted to the original registration department 6 months prior to the expiration of the term of validity.
Except as provided for in the third paragraph of this article, the food and drug administration under the provisions of the provisions of this article shall, before the expiration of the validity of the medical instrument registration certificate, make a decision on the approval of the extension. If it fails to make a decision within the time limit, it shall be deemed to be granted.
In case of any of the following circumstances, the registration shall not be extended:
(1) the registrant has not submitted the application for continued registration within the prescribed time limit;
(two) the mandatory standards for medical devices have been revised, and the medical equipment that has been applied for continued registration can not meet the new requirements;
(three) the medical device registration certificate which is not needed within the prescribed time limit shall be prescribed for medical instruments that are urgently needed for the treatment of rare diseases and in response to public health emergencies.
Sixteenth of the newly developed has not been included in the directory of medical devices, the applicant may in accordance with the provisions of this Ordinance relating to the third types of medical equipment products registered shall directly apply for product registration, can also determine the product categories according to the classification rules after confirmation in accordance with the regulations for registration or filing products to the State Food and drug supervision and management departments for categories and.
Where the registration of third types of medical device products is directly filed, the food and drug administration under the State Council shall determine the categories according to the degree of risk, and shall promptly register the medical instruments that are allowed to be registered in the classified catalogue. Where the application category is confirmed, the food and drug administration under the State Council shall, within 20 working days from the date of accepting the application, decide on the category of the medical device and notify the applicant.
Seventeenth, the first class of medical device products for the record, there is no need for clinical trials. For the registration of second or third types of medical device products, clinical trials shall be carried out; however, in any of the following circumstances, they may be exempted from clinical trials:
(1) the work mechanism is clear, the design is stereotyped, the production technology is mature, and the same kind of medical instruments have been used for many years, and there is no serious adverse events recorded, without changing the conventional use;
(two) it can be proved that the medical instrument is safe and effective through non clinical evaluation;
(three) it can be proved that the medical instrument is safe and effective by analyzing and evaluating the clinical data obtained from the clinical trials or clinical use of the same kind of medical instruments.
The catalogue of medical instruments exempted from clinical trials shall be formulated, adjusted and promulgated by the food and Drug Administration of the state council.
Eighteenth medical equipment to carry out clinical trials, clinical trials of medical devices shall be in accordance with the norms of quality management requirements in clinical trial institutions have the appropriate conditions, and proposed the relevant province, autonomous regions and municipalities directly under the people's government food and drug supervision and management departments for the record to clinical trials. The food and drug administration department that accepts the clinical trial record shall notify the competent departments of food and Drug Administration and the competent departments of health and family planning at the same level where the clinical testing institution is located.
Medical device clinical trial institutions for the record management. Clinical trials of medical institutions should have the conditions and record management and quality of clinical trial management practices, by the State Food and drug administration under the State Council and the health planning departments to develop and publish.
Nineteenth of the third types of medical devices for clinical trials, the human body has a higher risk, should be approved by the food and Drug Administration of the state council. The catalogue of third types of medical instruments with high risks to the human body in the clinical trials shall be formulated, adjusted and promulgated by the food and Drug Administration of the state council.
The food and drug supervision and Administration Department of the State Council for examination and approval shall be assumed for clinical trials, clinical trials of Medical Devices Agency equipment, professional staff and other conditions, the degree of risk of the medical device, clinical test scheme, the clinical benefit of comprehensive analysis and comparative risk analysis report. If a clinical trial is granted, it shall notify the proponent of clinical trials and the Department of food and Drug Administration of the people's Government of the province, autonomous region or municipality directly under the central government where the clinical trial institution is located, and the competent department of health and family planning.
The third chapter medical equipment production
Article twentieth engaging in the production of medical devices shall meet the following conditions:
(1) production sites, environmental conditions, production equipment and professional technical personnel suitable for the production of medical equipment;
(two) the institutions that have the quality inspection of the medical instruments produced, or the full-time inspection personnel and the inspection equipment;
(three) there is a management system to guarantee the quality of medical devices;
(four) have the after-sales service ability that adapts to the medical equipment that produces;
(five) requirements of product development and production process documents.
Twenty-first in the first class of medical equipment production, the production enterprises to the local districts of the food and Drug Administration Department of Municipal People's government for the record and submit proof of the data meet the conditions stipulated in article twentieth of the ordinance.
Twenty-second in second categories, third types of medical equipment production, production enterprises shall apply to the local province, autonomous regions and municipalities directly under the central government, food and drug supervision and management departments for the production license and submit proof of the data meet the conditions stipulated in article twentieth of the regulations and the production of medical devices registration certificate.
Acceptance of food and drug supervision and management departments of production license application shall examine the application materials within 30 working days from the date of acceptance check according to the State Food and Drug Administration of medical device production quality management specification. Those who meet the prescribed conditions shall be given permission and issued medical device production licenses; if they do not meet the requirements, they shall not grant permission and shall write a written explanation.
The medical device production license is valid for 5 years. If the expiration of the term of validity needs to be continued, the extension formalities shall be carried out in accordance with the relevant laws and regulations concerning administrative licensing.
Twenty-third medical equipment production and quality management practices should be for medical equipment design and development, production equipment, raw materials procurement, production process control of enterprises, institutions and personnel of medical safety and effective matters to make specific provisions.
Twenty-fourth medical equipment production enterprises shall be in accordance with the production of medical equipment quality management standards, establish and improve the production of medical equipment to adapt to the quality management system and ensure its effective operation; in strict accordance with the registration or filing for the technical requirements of the organization of production, ensure that the medical equipment factory in accordance with the mandatory standards and requirements for registration or filing for the record product technology.
The medical device manufacturer shall periodically check the operation of the quality management system and submit a self-examination report to the food and Drug Administration of the people's Government of the province, autonomous region or municipality directly under the central government.
Changes in twenty-fifth medical equipment manufacturing enterprises, no longer meet the requirements of quality management system for medical devices, medical equipment production enterprises shall immediately take corrective measures; may affect the safety and effectiveness of a medical device, should immediately stop production activities, and report to the local people's government at the county level food and drug supervision and administration department.
Twenty-sixth medical devices should use a common name. The generic name shall conform to the naming rules for medical devices formulated by the food and Drug Administration of the state council.
Twenty-seventh medical instruments should have instructions and labels. The contents of the instructions and labels shall be consistent with those registered or filed.
The specifications and labels of medical devices shall indicate the following items:
(a) general name, type and specification;
(two) the name and address of the manufacturing enterprise, the address of production and the way of contact;
(three) number of technical requirements of the product;
(four) the date of production and the period of use or the date of expiry;
(five) product performance, main structure and applicable range;
(six) contraindications, precautions and other matters that need warning or prompt;
(seven) installation and use of instructions or diagrams;
(eight) maintenance and maintenance methods, special storage conditions and methods;
(nine) other requirements shall be indicated in the technical requirements of the product.
Second types and third types of medical devices shall also indicate the medical device registration number and the name, address and contact information of the medical device registrant.
Medical instruments that are used by the consumers themselves shall also have special instructions for safe use.
Article twenty-eighth commissioned the production of medical equipment, commissioned by the parties entrusted with the quality of medical equipment commissioned. The entrusted party shall be a manufacturer of medical equipment in conformity with the provisions of these regulations and with corresponding production conditions. The entrusting party shall strengthen the management of the production behavior of the entrusted party and ensure that it is produced according to the statutory requirements.
The implantable medical instruments with high risk shall not be entrusted to production, and the specific catalogue shall be formulated, adjusted and promulgated by the food and Drug Administration of the state council.
The fourth chapter deals with the operation and use of medical devices
The twenty-ninth is engaged in medical equipment business activities should be commensurate with the scale and scope of business premises and storage conditions, and adapt with the medical device operation quality management system and quality management institutions or personnel.
The thirtieth is engaged in second types of medical equipment business, by business enterprises to the local districts of the food and Drug Administration Department of Municipal People's government for the record and submit proof of the data meet the conditions stipulated in article twenty-ninth of the ordinance.
The thirty-first is engaged in third types of medical equipment business, the operating enterprise shall, to the local people's Government of the districted city food and drug supervision and management departments to apply for business license and submit proof of the data meet the conditions stipulated in article twenty-ninth of the ordinance.
The food and drug administration shall accept the examination within 30 working days from the date of acceptance of the application, and organize the verification if necessary. Those who have met the prescribed conditions shall be given permission and issued a business license for medical devices; if they do not meet the requirements, they shall not grant permission and shall give reasons in writing.
The medical equipment business license is valid for 5 years. If the expiration of the term of validity needs to be continued, the extension formalities shall be carried out in accordance with the relevant laws and regulations concerning administrative licensing.
Article thirty-second medical equipment business enterprise and the use unit purchases the medical appliance, should examine the supplier 's qualifications and the medical equipment certificate of proof, establishes the purchase inspection record system. Enterprises engaged in the wholesale sale of second types and third types of medical instruments and third types of retail sales of medical devices shall also set up sales records system.
Record items include:
(1) the name, type, specification and quantity of medical instruments;
(two) batch number, validity period and date of sale of medical instruments;
(three) the name of the manufacturing enterprise;
(four) the name, address and contact information of the supplier or buyer;
(five) relevant license, document number, etc..
The purchase inspection records and sales records shall be true, and shall be kept in accordance with the time limit prescribed by the food and Drug Administration of the state council. The State encourages the adoption of advanced technology.
Thirty-third transport and storage of medical devices, medical devices shall comply with the specifications and labeling requirements; have special requirements for temperature, humidity and other environmental conditions, shall take appropriate measures to ensure the safety and effectiveness of medical instruments.
Thirty-fourth units for the use of medical devices shall have storage places and conditions suitable for the variety and quantity of medical instruments used. Medical device users shall strengthen technical training for their staff and use medical instruments in accordance with product specifications, technical operation specifications and so on.
Unit configuration of large medical equipment medical equipment, large medical equipment configuration planning should be in line with the state health departments to develop, and its function, adapt to demands of clinical service, professional and technical personnel with technical conditions and corresponding facilities and have the corresponding qualifications, ability, and by the people's governments at or above the provincial level health supervisor the approval of the Department, have large medical equipment configuration permits.
The measures for the administration of the allocation of large medical equipment shall be formulated by the competent department of health and family planning under the State Council in conjunction with the relevant departments under the state council. The catalogue of large medical equipment shall be submitted by the competent department of health and family planning of the State Council to the relevant departments under the State Council and submitted to the State Council for approval before implementation.
Thirty-fifth medical devices used by the unit for repeated use of medical equipment should be in accordance with the State Council Health and family planning department for disinfection and management of the provisions of the treatment.
The disposable medical instruments shall not be reused, and the used ones shall be destroyed and recorded in accordance with the relevant regulations of the state.
Thirty-sixth medical devices used to require regular inspection, testing, calibration, maintenance, maintenance of medical equipment, shall carry out the inspection, in accordance with the product specifications and requirements of inspection, calibration, maintenance, maintenance and record, analyze and evaluate timely, ensure medical equipment in good condition, ensure service quality; for large medical equipment the use of the long term, should be established by Taiwan using archives, records the use, maintenance, transfer, the actual use of such matters. The period of record keeping shall not be less than 5 years after the expiration of the prescribed time limit for the medical device.
Thirty-seventh units for medical devices should properly keep the original data of the third types of medical devices and ensure that the information is traceable.
The use of large medical devices and implants and medical devices shall intervene, name, medical equipment and other information and key technical parameters and quality are closely related to the safety of the information necessary to medical records related record.
Thirty-eighth found that the use of medical devices, there are security risks, the use of units of medical devices should be stopped immediately and inform production enterprises or other institutions responsible for product quality maintenance; maintenance of the use of medical devices still can not meet the safety standards, may not continue to use.
Thirty-ninth food and drug administration departments and health and family planning departments in accordance with their respective responsibilities, respectively, on the use of medical equipment quality and medical device use behavior supervision and management.
Fortieth medical device business enterprises, the use of units shall not operate or use, has not been registered according to law, no qualified documents and expired, invalid, eliminated medical devices.
Between the forty-first medical devices used in the transfer of medical equipment, the transferor shall ensure the transfer of medical equipment is safe and effective, shall not transfer the expired, failure, out of and unqualified medical instruments.
Forty-second imported medical instruments shall be medical devices registered or filed in accordance with the provisions of the second chapter of these regulations.
The imported medical instruments shall have Chinese instructions and labels in chinese. The instructions and labels shall comply with the requirements of these regulations and the relevant mandatory standards, and shall clearly state the origin of medical devices, the name and address of the agent as well as the way of contact in the instruction. No Chinese manuals, Chinese labels or instructions or labels that are not in conformity with the provisions of this article shall not be imported.
Forty-third entry-exit inspection and quarantine institutions shall examine the imported medical instruments according to law, and those who have failed the inspection shall not be allowed to import.
The food and drug administration under the State Council shall promptly notify the State Administration for entry exit inspection and Quarantine of the registration and filing of imported medical instruments. Where the port of entry is located, the entry exit inspection and quarantine institution shall promptly notify the food and Drug Administration of the Municipal People's government at the place where the site is located to report the customs clearance of the imported medical instruments.
Article forty-fourth enterprises exporting medical instruments shall ensure that the medical instruments they export meet the requirements of the importing countries (regions).
Forty-fifth advertisements for medical devices shall be true and lawful, and shall not contain false, exaggerated or misleading content.
Advertisements of medical devices shall be approved by the medical device manufacturers or agents of imported medical instruments of the provinces, autonomous regions and municipalities directly under the people's government food and drug supervision and administration department for examination and approval, and approval of medical advertising. The advertisement publish advertisements of medical devices, the approval documents shall be checked prior to advertising and its authenticity; shall not be released without obtaining approval documents, the authenticity of the unverified or advertising content inconsistent with the documents of approval of medical advertising. The food and drug administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall publish and update in time the catalogues of the approved medical device advertisements and the contents of the advertisements approved.
The food and Drug Administration of the people's government at or above the provincial level shall order the suspension of the production, sale, import and use of medical instruments, and shall not issue any advertisement involving the medical device during the suspension.
The measures for the examination of advertisements for medical devices shall be formulated by the food and drug administration under the State Council in conjunction with the administrative department for Industry and commerce under the state council.
The fifth chapter deals with the treatment of adverse events and the recall of medical devices
Forty-sixth countries to establish medical equipment adverse event monitoring system, medical equipment adverse events in a timely manner to collect, analyze, evaluate and control.
Forty-seventh operation of medical equipment production enterprises, units should use the medical devices to the production or use carry out the monitoring of adverse events; find the medical device adverse event or suspicious adverse events, should be in accordance with the provisions of the State Food and drug administration, to report to the medical device adverse event monitoring agencies.
Any unit or individual who discovers any medical device adverse event or suspected adverse event shall have the right to report to the food and Drug Administration or the medical device adverse event monitoring technical organization.
Forty-eighth the State Council's food and drug administration shall strengthen the medical device adverse event monitoring information network construction.
Medical device adverse event monitoring institutions should strengthen the medical device adverse event monitoring information, take the initiative to collect information on adverse events; adverse events or adverse event reports received, shall promptly verify, investigation, analysis, assessment of adverse events, and to the food and drug supervision and management departments and health departments advise.
The medical device adverse event monitoring technical institution shall announce the way of contact so as to facilitate the medical device production and operation enterprises and the employing units to report adverse events of medical devices.
Forty-ninth food and drug administration departments shall, in accordance with the assessment results of medical devices adverse events, timely release warning information, and ordered to suspend production, sale, import and use of control measures.
The people's governments at or above the provincial food and drug supervision and management departments should be in conjunction with the health planning departments and relevant departments to organize the investigation and handling of medical adverse events causing serious injury or death, sudden mass in a timely manner, and to strengthen the monitoring of similar medical devices.
Article fiftieth medical equipment production enterprises and units shall cooperate with the medical device adverse event monitoring technical organization and the investigation of adverse medical device incidents carried out by the food and drug administration.
Article fifty-first under one of the following circumstances, the food and Drug Administration of the people's government at or above the provincial level shall make a re evaluation of the registered medical device organization:
(1) in accordance with the development of scientific research, there has been a cognitive change in the safety and effectiveness of medical devices;
(two) adverse events monitoring and evaluation of medical devices show that medical devices may be defective;
(three) other circumstances requiring re evaluation as prescribed by the food and Drug Administration of the state council.
Re evaluation shows that the registered medical devices can not be guaranteed to be safe and effective, and the medical registration certificate will be cancelled and announced to the public by the original issuing department. Medical devices that have been registered for medical equipment registration shall not be produced, imported, operated or used.
Fifty-second medical equipment manufacturing enterprises producing medical devices found to not meet the mandatory standards, the registration or filing for the technical requirements of the product or the presence of other defects, should immediately stop production, notify the relevant production enterprises, the use of units and consumers to stop the operation and use of medical devices, the recall has been listed for sale, remedial destroy such measures, record the relevant circumstances, publish relevant information, and the medical device recall and treatment planning departments to report to the Department of food and Drug Administration and health.
Business of medical devices medical devices found operating the existence of the circumstance specified in the preceding paragraph, it shall immediately cease operations, notify the relevant production enterprises, the use of units, consumers, and record the stop of operation and notice. Medical device manufacturers believe that medical devices that need to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.
If the medical device manufacturing enterprise fails to implement the recall or cease operation according to the provisions of this article, the food and drug administration may order it to recall or stop the operation.
The sixth chapter is supervision and inspection
The fifty-third food and drug administration shall strengthen the supervision and inspection of the registration, filing, production, operation and use of medical devices, and carry out the key supervision and inspection of the following matters:
(1) whether or not the medical device manufacturing enterprise organizes production in accordance with the product or technical requirements registered or filed;
(two) whether the quality management system of medical device manufacturers keeps effective operation?;
(three) whether the production and operation conditions of the enterprises engaged in the production and operation of medical equipment are consistent with the statutory requirements.
Article fifty-fourth food and Drug Administration in the supervision and inspection of the following functions and powers:
(1) to enter the site for inspection and sampling;
(two) consulting, copying, sealing up and detaining relevant contracts, bills, books and other relevant materials;
(three) sealing up and seizing medical equipment, illegal parts, raw materials and tools and equipment used in the illegal production of medical equipment, which do not meet the statutory requirements;
(four) sealing up the place for engaging in the production and operation of medical instruments in violation of the provisions of these regulations.
Where the food and Drug Administration conducts supervision and inspection, it shall show its law enforcement certificates and keep the commercial secrets of the inspected entity.
The units and individuals concerned shall cooperate with the supervision and inspection of the food and drug administration, and shall not conceal the relevant information.
Fifty-fifth damage to the human body or medical evidence that may be harmful to human health, food and drug supervision and management departments can be taken to suspend production, import, management and use of emergency control measures.
Fifty-sixth food and drug supervision and administration departments should strengthen the medical device production enterprises and the use of units of production, management and use of medical equipment spot checks. No inspection fees or any other fees shall be collected for spot checks, and the necessary expenses shall be included in the budget of the government at the corresponding level. The food and Drug Administration of the people's governments at or above the provincial level shall publish the quality control of medical devices in a timely manner in accordance with the conclusion of random inspection.
Health planning departments should be on the use of large medical equipment status monitoring and evaluation; found illegal use and excessive examination, and large medical equipment over treatment and other circumstances, should be corrected immediately, shall be handled according to law.
Fifty-seventh medical device inspection institutions qualification work in accordance with relevant state regulations, the implementation of unified management. The certification and Accreditation Administration of the State Council shall, in conjunction with the inspection institutions approved by the food and Drug Administration of the State Council, be subject to the examination of medical instruments.
Where the food and drug administration needs to examine the medical instruments in the work of law enforcement, it shall entrust the qualified medical device inspection institution to pay the relevant fees.
If the party disagrees with the inspection results, it may, within 7 working days from the date of receipt of the inspection conclusion, select a qualified medical device inspection institution for re examination. The medical equipment inspection institution that undertakes the re examination work shall make a re examination conclusion within the time prescribed by the food and Drug Administration of the state council. The conclusion of reinspection is final test conclusion.
Fifty-eighth of the medical devices may have harmful substances or change the medical hidden safety problems in design, raw materials and production technology and the medical devices in accordance with national standards and industry standards inspection items and methods to test the medical device testing institutions can supplement the inspection items and methods of inspection; inspection conclusion method check on the test items, the approval of the State Food and drug administration, can be used as food and drug supervision and management departments to identify medical devices on the basis of quality.
Fifty-ninth districts of the city and County People's government food and drug supervision and management departments should strengthen supervision and inspection of medical device advertising; found without approval or tampering with the advertising content of the approved medical advertisements, apply to the local province, autonomous regions and municipalities directly under the Central People's government food and drug supervision and Administration Department report, by the to the public.
The administrative department for Industry and Commerce shall, in accordance with the provisions of the relevant laws and administrative regulations on advertising administration, supervise and inspect the advertisements for medical devices, and investigate and deal with illegal activities. Where the food and drug administration finds that the illegal publication of medical device advertisements, it shall make recommendations for the handling of such advertisements and transfer them to the administrative departments for Industry and commerce at the same level in accordance with relevant procedures.
Sixtieth, the State Council food and drug administration to establish a unified medical equipment supervision and management information platform. The food and drug administration shall, through the information platform, timely announce the daily supervision and management information of medical device license, record keeping, spot check inspection and investigation and investigation of illegal acts. However, the parties may not disclose the business secrets.
The food and drug administration shall establish a credit file for the medical device registrant and the record holder, the production and operation enterprises and the employing units, and increase the frequency of supervision and inspection of the bad credit records.
Sixty-first departments such as food and drug administration shall publish their contact ways and accept consultation, complaint and report. The departments of food and Drug Administration and other departments concerned shall reply promptly when receiving consultation on the supervision and administration of medical devices. When receiving complaints or reports, they shall promptly verify, handle and respond to them. The consultation, complaint, report and the reply, verification and treatment shall be recorded and kept.
The report on the development, production, operation and use of medical instruments is true after investigation, and the departments of food and drug administration shall give rewards to informants.
The formulation, sixty-second of the State Food and drug administration to adjust and modify the provisions of this Ordinance and directory specification and medical equipment supervision and management of the public opinions shall be solicited; through hearing and argumentation and other forms, to listen to the experts, medical equipment production and operation of enterprises and units, consumers and related organization views.
The seventh chapter, legal responsibility
Sixty-third any of the following circumstances, the people's governments at or above the county level by the food and drug supervision and administration department shall confiscate the illegal income, illegal production and operation of medical equipment and for illegal production and management tools, equipment, raw materials and other items; lack of illegal production and operation of medical equipment total value of 10 thousand yuan, and fined 50 thousand yuan to 100 thousand yuan; the value of the amount of more than 10 thousand yuan, and the total value of 10 times more than 20 times the fine; if the circumstances are serious, the relevant responsible person of medical license and enterprise application is not accepted within 5 years:
(1) producing and operating second or third kinds of medical apparatus without obtaining medical equipment registration certificates;
(two) engaging in the production of second or third types of medical apparatus without permission;
(three) engaging in the operation of third types of medical devices without permission.
In the case of the first item mentioned in the preceding paragraph, if the circumstances are serious, the original license issuing department shall revoke the medical device production license or the medical equipment operation permit.
Unauthorized use of the configuration of large medical equipment, by the people's governments at or above the county level health administrative department shall be ordered to stop the use, give a warning, confiscate the illegal income; the illegal gains and impose a fine of less than 10 thousand yuan, 10 thousand yuan and 50 thousand yuan; the illegal income of more than 10 thousand yuan, 5 times the illegal income and impose less than 10 times fine; if the circumstances are serious, large medical equipment configuration permits the responsible person and the unit will not be accepted within 5 years.
Article sixty-fourth provides false information or by other fraudulent means to obtain medical device registration certificate, production license, medical device license, medical equipment, large medical equipment configuration permits advertising approval documents of license, the original license issuing authority to revoke the license has been obtained, and impose a fine of 50 thousand yuan and 100 thousand yuan. Medical licensing unit responsible person and the application will not be accepted within 5 years.
Forged or altered, the sale, lease or loan related medical license, the original license issuing authority shall be confiscated or revoked, confiscate the illegal income; the illegal income is less than 10 thousand yuan, a fine of 10 thousand yuan and 30 thousand yuan; the illegal income of more than 10 thousand yuan, at more than 3 times the illegal income 5 times the fine; constitute acts violating the administration of public security, the public security organs in accordance with the law on administrative penalties for public security.
Sixty-fifth not in accordance with the regulations for the record, by the people's government at or above the county level food and drug supervision and management departments shall be ordered to make corrections within a time limit; if it fails to do so, to the public without registration unit and product name, may be fined 10 thousand yuan.
Provide false information for the record, by the people's government at or above the county level food and drug supervision and management departments to the public record unit and product name; if the circumstances are serious, the persons who are directly responsible shall be 5 years engaged in medical equipment production and business activities.
Sixty-sixth any of the following circumstances, a correction by the people's government at or above the county level food and drug supervision and administration department shall confiscate the illegal production, operation or use of the medical instruments; the illegal production and operation or use of the medical value of less than 10 thousand yuan, and a fine of 20 thousand yuan and 50 thousand yuan; the total value of 10 thousand yuan concurrently, the value of the amount of 5 times more than 10 times the fine; if the circumstances are serious, shall be ordered to cease, until the original license issuing authority shall cancel the medical device registration certificate, production license, medical equipment business license:
(1) production, operation or use of medical equipment that does not meet the mandatory standards or does not meet the technical requirements of the products registered or filed;
(two) the medical device manufacturer fails to organize production in accordance with the product or technical requirements registered or filed, or fails to establish a quality management system in accordance with the provisions of these regulations and to maintain effective operation;
(three) operating or using medical equipment without certificates of conformity, expired or expired or eliminated, or using medical equipment not registered in accordance with the law;
(four) the food and drug administration shall order it to recall or stop the operation after the implementation of the provisions of these regulations, but still refuses to recall or stop the operation of medical devices;
(five) entrusting enterprises that do not have the conditions stipulated in these regulations to produce medical instruments or manage the production behavior of the entrusted party.
Business enterprises, medical devices used to fulfill the provisions of this Ordinance, purchase inspection and other obligations, there is sufficient evidence to prove that it does not know the medical instruments management and use of the first and third provisions of medical cases, and truthfully reveals the source, may be exempted from punishment, but shall confiscate its business the use of medical devices, does not meet the statutory requirements.
Sixty-seventh any of the following circumstances, a correction by the people's government at or above the county level food and drug supervision and management departments shall impose a fine of 10 thousand yuan and 30 thousand yuan; if the circumstances are serious, shall be ordered to cease, until the original issuing department shall revoke the production license of medical equipment, medical equipment business license:
(1) the production conditions of medical device manufacturing enterprises have changed and are no longer in conformity with the requirements of the medical equipment quality management system, and they have failed to rectify or stop production or report in accordance with the provisions of these regulations;
(two) the production and operation instructions and labels are not in conformity with the medical instruments stipulated in these regulations;
(three) failing to transport or store medical instruments according to the specifications and labels of medical devices;
(four) in the case of transferring expired, invalid, eliminated or tested unqualified medical instruments.
Sixty-eighth any of the following circumstances, the people's governments at or above the county level by the food and drug supervision and management departments and health departments in accordance with their respective duties shall be ordered to correct, given a warning; refuse to correct, a fine of 5000 yuan and 20 thousand yuan; if the circumstances are serious, shall be ordered to cease, until the original license issuing authority shall cancel the production of medical devices the license and medical device license:
(1) the medical device manufacturer fails to submit the self-examination report of the quality control system as required;
(two) the medical device operating enterprises and the employing units have failed to establish and implement the medical equipment purchase inspection record system in accordance with the provisions of these regulations;
(three) the enterprises engaged in the wholesale operation of the second and third types of medical instruments and the retail business of the third types of medical instruments have not established and implemented the sales record system in accordance with the provisions of these regulations;
(four) the medical devices used repeatedly, and the units used for medical devices are not handled in accordance with the provisions of disinfection and management;
(five) the medical device unit uses the medical equipment that is used for a single use once again or fails to use the disposable medical instruments in accordance with the regulations;
(six) the need for regular inspection, testing, calibration, maintenance, maintenance of medical equipment, medical devices used not in accordance with the product specification requirements for inspection, inspection, calibration, maintenance, maintenance and recorded, analyzed and evaluated in a timely manner, to ensure that medical equipment in good condition;
(seven) the use of medical devices unit fails to properly preserve the original data acquisition of third types of medical equipment, or not in accordance with the provisions of the large medical devices and implants and medical devices in medical records and other related information recorded in the record;
(eight) the medical devices used by medical devices are found to have hidden dangers of safety, which have not been stopped immediately, notified, repaired, or continued to use medical instruments that have not been used for safety standards after inspection and maintenance;
(nine) the use of large medical equipment by medical device manufacturers can not guarantee the quality and safety of medical treatment;
(ten) medical equipment production enterprises, the use of units did not carry out the medical device adverse event monitoring in accordance with the regulations, not in accordance with the requirements of reports of adverse events, or to carry out medical device adverse event monitoring institutions, food and drug supervision and management departments of the adverse event investigation refuses to cooperate.
Sixty-ninth in violation of the regulations of medical devices to carry out clinical trials by the people's government at or above the county level, food and drug supervision and administration department shall order rectification or stop clinical trials, may be fined 50 thousand yuan; causing serious consequences, demotion, dismissal or expulsion of the directly responsible personnel in charge and other directly responsible personnel in accordance with the law; the organization within 5 years shall not carry out related clinical trials of medical devices.
Clinical trials of medical institutions issued a false report by the people's government at or above the county level, food and drug supervision and administration department for more than 50 thousand yuan to 100 thousand yuan fine; the illegal gains, confiscate the illegal income; the directly responsible personnel in charge and other directly responsible personnel, in accordance with the law for dismissal or expulsion; the agency within 10 years not to carry out related clinical trials of medical devices.
Seventieth medical equipment inspection agency issued a false inspection report, the competent authorities by awarding qualification revoke the qualification examination, finds that the application does not accept the qualification within 10 years; a fine of 50 thousand yuan and 100 thousand yuan; the illegal gains, confiscate the illegal income; the directly liable person in charge and other directly responsible personnel. Give dismissal or expulsion according to law; is expelled, shall not be engaged in medical equipment inspection work within 10 years from the date of decision making.
Seventy-first in violation of the regulations, issued without obtaining approval documents of medical advertisement, authenticity verification without prior approval document is issued medical advertising, or advertising content inconsistent with the documents of approval of medical advertising, the administrative department for Industry and Commerce shall be punished in accordance with relevant laws and administrative regulations on the administration of advertisements.
Where the contents of an approved medical device are tampered with, the original license issuing department shall revoke the advertisement approval document of the medical device and shall not accept the advertisement examination and approval application within 2 years.
The publication of false advertising of medical devices, by the provincial people's government food and drug supervision and administration department decided to suspend the sale of the medical equipment, and to the public; still the sales of medical devices, by the people's government at or above the food and drug supervision and Administration Department confiscated medical equipment and illegal sales, and impose a fine of 20 thousand yuan and 50 thousand yuan.
Seventy-second medical institutions, the technical evaluation of medical device adverse event monitoring agencies did not perform their duties in accordance with the regulations, the review and monitoring of major mistakes, corrections by the people's government at or above the food and drug supervision and management departments shall submit the criticism, given a warning; causing serious consequences, the directly responsible person in charge and other directly responsible personnel, demotion, dismissal or expulsion according to law.
Seventy-third food and drug supervision and management departments, health departments and their staff shall be strictly in accordance with the regulations of the punishment of the type and magnitude according to the nature of illegal behavior and the specific circumstances of the exercise of administrative punishment, specific measures for planning departments according to their respective duties shall be formulated by the state food and drug supervision and management departments, health.
Seventy-fourth in violation of the regulations, the people's governments at or above the county level food and drug supervision and administration department or other relevant departments do not fulfill the duties of supervision and administration of medical devices or breach of privilege, dereliction of duty, given a warning, the supervisory organ or organ the directly liable person in charge and other directly responsible personnel shall be a demerit or demerits punishment; cause serious consequences, demotion, dismissal or expulsion.
Article seventy-fifth in violation of the provisions of these regulations, constitute a crime, according to law shall be held criminally responsible; causing personal, property or other damage, according to law shall bear the responsibility for compensation.
The eighth chapter is the supplementary provisions
Seventy-sixth the meaning of the following terms in this ordinance:
Medical equipment, refers directly or indirectly to the body of the apparatus, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including the need for computer software; the utility is mainly through the physical way, not by pharmacology, immunology or metabolism, or although there are these participate but only play a supporting role; its purpose is to:
(1) diagnosis, prevention, care, treatment, or remission of diseases;
(two) diagnosis, monitoring, treatment, remission, or functional compensation of injuries;
(three) examination, substitution, regulation, or support of physiological structure or physiological process;
(four) the support or maintenance of life;
(five) pregnancy control;
(six) providing information for medical or diagnostic purposes by examining samples from the human body.
Units of medical equipment, refers to the use of medical devices to provide medical and other technical services for other institutions, including medical institutions to obtain a license to practice medical institutions, make family planning technical service institution of the family planning technical service institutions, and the law is not required to obtain a license to practice medical institutions, the blood plasma collection stations rehabilitation aids, adaptation mechanism etc..
Large medical equipment refers to large medical equipment with complicated technology, large amount of capital input, high operation cost, great influence on medical expenses and catalogue management.
Seventy-seventh medical device products can be charged for registration. The specific charging items and standards shall be formulated by the departments of Finance and pricing under the State Council in accordance with the relevant provisions of the state.
Seventy-eighth nonprofit management measures contraceptive medical equipment and medical institutions to deal with public health emergencies and medical devices developed by the measures for the administration of food and drug supervision and Administration Department of the State Council for health authorities to develop.
Medical equipment management, by the food and drug supervision and Administration Department of the State Council administrative department of traditional Chinese medicine on the basis of the provisions of regulation; scope of rehabilitation aids medical devices and management practices, by the State Food and Drug Administration will with the Civil Affairs Department of the State Council according to the provisions of these regulations formulated.
The supervision and administration of the use of medical equipment in the seventy-ninth Army shall be organized and implemented by the competent department of military health in accordance with these regulations and the relevant provisions of the armed forces.
These eightieth regulations shall come into force on June 1, 2014.