Decree of the state council of the People's Republic of China
No. 650

The regulations on the supervision and administration of medical devices is 39th on February 12, 2014, the state council executive meeting of the revision, will now be revised regulations on the supervision and administration of medical devices, effective as of June 1, 2014.
Premier li keqiang
On March 7, 2014

Medical device supervision and management regulations
(January 4, 2000, the state council of the People's Republic of China has announced on February 12, 2014, no. 2014 is 39th of the state council executive meeting to revise by)

The first chapter is always

Article 1 in order to ensure the safety of medical equipment, effective, safeguard human health and life safety, these regulations are formulated.
Article 2 within the territory of the People's Republic of China engaged in medical equipment development, production, management, use activity and its supervision and administration, shall abide by these regulations.
Article 3 the food and drug supervision and administration department under the state council is responsible for the supervision and administration of medical devices nationwide.The relevant departments of the state council within the scope of their respective duties is responsible for supervision and management of the work related to medical equipment.
Local people's governments at or above the county level to the food and drug supervision and administration department shall be responsible for the supervision and administration of medical devices in their respective administrative areas.The local people's governments at or above the county level authorities within the scope of their respective duties is responsible for the supervision and administration work related to medical equipment.
The food and drug supervision and administration department under the state council shall cooperate with the relevant departments of the state council, to implement the national medical equipment industry planning and policy.
Article 4 the state shall carry out the policy of classification administration of medical apparatus and instruments according to the degree of risk.
The first is the low degree of risk, the conventional management can ensure the safe and effective medical devices.
The second category is a moderate risk, management must be strictly controlled to ensure its safe and effective medical devices.
The third kind is with high risk, need to take special measures to strictly control the management to ensure the safe and effective medical devices.
To evaluate the risk degree of medical equipment, should consider the intended purpose of medical apparatus and instruments, structure characteristic, using method and other factors.
The food and drug supervision and administration department under the state council is responsible for medical device classification rules and classification catalogues, and according to the medical equipment production, management, usage, timely analysis and evaluation to the risk of medical apparatus and instruments change, adjust the catalogs.Formulate, adjust the catalogs, ought to fully listen to the medical device production enterprise and the use of units, the opinions of the industry organization, the international medical device classification practice and reference.The catalogs of medical devices shall publish to the society.
Article 5 the development of medical devices shall comply with the principles of safe, effective and economical.The state encourages research and innovation of medical apparatus and instruments, giving play to the role of market mechanism, promote the promotion and application of new technology of medical equipment, promote the development of medical equipment industry.
Article 6 of the medical device products shall conform to the medical apparatus and instruments mandatory national standards;There is no mandatory national standards, shall conform to the compulsory medical devices industry standards.
Disposable medical equipment directory by the food and drug supervision and administration department under the state council jointly with the departments of family planning of public health under the state council, formulate, adjust and publish.Reuse can guarantee the safe and effective medical apparatus and instruments, not included in the disposable medical device directory.For the design, the production process, such as disinfection sterilization technology improved reuse can guarantee the safe and effective medical apparatus and instruments, shall be adjusted the disposable medical device directory.
Article 7 for medical devices industry organization should strengthen self-discipline, promoting the construction of credit system, supervise and urge enterprise production and operation activities in accordance with the law, guide the company honest and trustworthy.

The second chapter medical equipment product registration and for the record

Article 8 class I medical devices shall manage the product for the record, the second, third class medical equipment product registration management.
Article 9. The first kind of medical equipment products for the record and apply for the second, third class medical equipment product registration, shall submit the following information:
(a) product risk analysis data;
(2) the product technical requirements;
(3) the product inspection report;
(4) clinical evaluation data;
(5) product manual and label sample;
(6) related to product development, production of quality management system documents;
(7) to prove that product safety, effective, other information as needed.
Medical device registration of applicant, for the record shall be responsible for the authenticity of the submitted data.
Article 10 the first kind of medical equipment products for the record, and by the record to the local districts municipal food and drug supervision and administration department of the people's government submit for the record.Among them, the product inspection report can be put on record the self-check report;Clinical evaluation data do not include clinical trial report, same products can be through the literature, the clinical use of data show that the safe and effective information of medical equipment.
Class I medical devices shall be exported to the territory of China of foreign enterprises, by its representative offices established in the territory of China or designated enterprise as a legal person as agent within the territory of China, submitted to the food and drug supervision and administration department under the state council for the record data and record people's country (region) permitted by the competent department of the medical equipment sale proof document.
Record data include the contents change, ought to be changed to the original registration department for the record.
Article 11 to apply for the second category of medical device product registration, registration of the applicant shall, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government for the food and drug supervision and management departments to submit registration information.To apply for the third class medical equipment product registration, registration applicant shall submit to the food and drug supervision and administration department under the state council an application for registration information.
To export category ii and class iii medical devices in our country's overseas production enterprise, should by its representative offices established in the territory of China or designated enterprise as a legal person as agent within the territory of China, to the food and drug supervision and administration department under the state council shall submit an application for registration information and registration of the applicant's country (region) permitted by the competent department of the medical equipment market.
The second, third class medical equipment product registration information in the product inspection report should be issued by the medical device testing institutions inspection report;Clinical evaluation should include clinical trial report, but in accordance with the provisions of article 17 of these regulations except from clinical trials of medical devices.
Article 12 accepts the application for registration of the food and drug supervision and administration department shall within three working days from the date of acceptance of the application for registration information transfer technical evaluation institutions.After technical evaluation institution shall upon completion of technical review to submit the review opinions to the food and drug supervision and administration department.
Article 13 the accepts the application for registration of the food and drug supervision and administration department shall receive the review opinions within 20 workdays as of the date of decision.To meet the requirements of the safe, effective, and approving the registration shall be issued to the medical device registration certificate;Does not meet the requirements, shall be rejected for registration and explain the reasons in writing.
The food and drug supervision and administration department under the state council in the organization of import medical instrument technical review considers necessary to inspect the quality management system, shall organize the quality management system to check technical institutions to carry out the quality management system verification.
Article 14 registered first class ii and class iii medical devices products, its design, raw materials, production process, the applicable scope, using methods such as substantive change, is likely to affect the medical equipment safety, effective, registrant shall apply for alteration registration procedures to the original registration department.The substantial change, do not affect the medical equipment safety, effective, should be changes to the original registration department for the record.
Article 15 medical device registration certificate is valid for five years.Need to continue to the expiration of the valid period of registration, it shall, before the expiration of six months to the original registration authorities for the continuation of registration application.
Except the circumstances mentioned in paragraph 3, received a continuation of application for registration of the food and drug supervision and administration department shall, prior to the expiration of the valid period of the medical device registration certificate, make a decision on granting a continuation.Fails to make a decision, as granted.
Any of the following circumstances, the registration shall not continue:
(a) the registrant is not proposed for registration within a prescribed period of time;
(2) medical instruments mandatory standard has been revised, application for registration of medical device cannot meet the new requirements;
(3) used in the treatment of rare diseases and respond to public health emergencies in urgent need of medical apparatus and instruments, not complete medical device registration certificate shall specify matters within a prescribed period of time.
Article 16 of the newly developed has not been listed in the catalog of medical apparatus and instruments, the applicant may, in accordance with the regulations related to the regulation of the third class medical equipment product registration directly apply for product registration, can also according to the classification rules determine the product category and applied to the food and drug supervision and administration department under the state council for type confirmed in accordance with the provisions of these regulations apply to register or for a product for the record.
Directly apply for the third class medical equipment product registration, the food and drug supervision and administration department under the state council shall be determined according to the degree of risk categories, to grant registration of medical devices into the catalog in a timely manner.Application category confirmation, the food and drug supervision and administration department under the state council shall within 20 workdays as of the date of acceptance of application to determine the categories of medical equipment and inform the applicant.
Article 17 the first kind of medical equipment products for the record, and do not need to undertake clinical trials.To apply for the second, third class medical equipment product registration, shall conduct clinical trials;But, in any of the following circumstances, can be from conducting clinical trials:
(a) clear working mechanism, design, production technology mature, listed with varieties of medical instrument clinical application for many years and no record of serious adverse events and not change the conventional purpose;
(2) through the clinical evaluation can prove the medical equipment safety and effective;
(3) through the varieties with medical devices clinical trials or clinical use for evaluating and analyzing the data to prove that the medical device safe and effective.
From clinical trials of medical devices directory by the food and drug supervision and administration department under the state council, formulate, adjust and publish.
Article 18 in the clinical trials of medical equipment, shall be in accordance with the requirements for the quality control standard for clinical trials of medical apparatus and instruments, the qualified institutions, clinical trials and clinical trials to forward the local people's governments of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department for the record.Clinical trials for the record of the food and drug supervision and administration department shall inform the clinical test units for the record the location of the food and drug supervision and administration departments at the same level and health departments of family planning.
Medical device clinical trial institution qualification authentication conditions and the quality control standard for clinical trials, by the food and drug supervision and administration department under the state council jointly with the departments of family planning of public health under the state council and promulgated;Medical device clinical trial institution by the food and drug supervision and administration department under the state council jointly with the departments of family planning of public health under the state council and published.
Article 19 the class iii medical devices for clinical trials has a high risk to the human body, shall be approved by the food and drug supervision and administration department under the state council.Clinical trials have higher risk to the human body of class iii medical devices directory by the food and drug supervision and administration department under the state council, formulate, adjust and publish.
The food and drug supervision and administration department under the state council for examination and approval of clinical trials of medical devices shall be assumed to clinical trial institution of equipment, professional conditions, the degree of risk for medical devices and clinical trial implementation plan, clinical benefit and risk analysis report, etc for comprehensive analysis.Granted to conduct clinical trials, cultivating clinical trials and clinical trials should be posted where the people's governments of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department and health department in charge of family planning.

Chapter iii medical device manufacturing

Article 20 the engaged in medical equipment production activities, shall meet the following conditions:
(a) and the production of medical apparatus and instruments that meet the needs of production sites, environmental conditions, production equipment and professional and technical personnel;
(2) have a medical apparatus and instruments of production quality inspection institution or full-time inspection personnel and inspection equipment;
(3) management system to ensure the quality of medical apparatus and instruments;
(4) there are adapted to production of medical equipment after-sales service ability;
(5) the requirements of the product development, production process documents.
Article 21 is engaged in production of class I medical devices, by the production enterprise to the local districts municipal food and drug supervision and administration department of the people's government for the record and submit the information of the evidence of compliance with requirements specified in article 20 of these regulations.
Article 22 in the second, third class medical equipment production, the production enterprise shall, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative department to apply for food production license and submit the information of the evidence of compliance with requirements specified in article 20 of these regulations as well as the production of medical device registration certificate.
Accept production licensing applications of the food and drug supervision and administration department shall within 30 working days from the date of acceptance of the application materials for review, according to the food and drug supervision and administration department under the state council of the medical device manufacturing quality management requirements of the specification for verification.To comply with the prescribed conditions, permission and given a medical device manufacturing license;Does not meet the prescribed conditions, no license and explain the reasons in written form.
Medical equipment production license is valid for five years.Need to continue to the expiration of the valid period of the law of administrative licensing in accordance with the relevant provisions of the procedure.
Article 23 shall be medical equipment production and the quality control standard for medical equipment design, development, production equipment conditions, raw materials procurement, production process control, enterprise's institutional setup and personnel matters affect medical devices such as safe and effective make that clear.
Article 24 of the medical device production enterprise shall, in accordance with the medical device production quality management norms, establish a sound and appropriate to the production of medical device quality management system and ensure its effective operation.After registration or registration of the product technology in strict accordance with the requirements of production, ensure that the factory of medical apparatus and instruments for filing, the products conform to the compulsory standards as well as a certified or technical requirements.
Medical device manufacturing enterprise shall regularly on the operation of the quality management system in the check list, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government and the food and drug supervision and administration department submit inspection report.
Article 25 the change of the medical device manufacturing enterprise production conditions, no longer meet the requirements of the medical device quality management system, medical device manufacturing enterprise should take immediate corrective actions;That may affect medical devices safe and effective, it shall immediately stop production activities, and to the local people's government at the county level the food and drug supervision and administration department report.
Article 26 the medical apparatus and instruments shall use the generic name.Generic names shall be in conformity with the food and drug supervision and administration department under the state council of the medical device naming convention.
Article 27 the medical apparatus and instruments shall have a manual, label.Specification, the content of the label shall be associated with a certified or registered content consistent.
Medical equipment instructions, labels shall clearly indicate the following items:
(a) generic names, types, specifications;
(2) production enterprise's name and domicile, production address and contact information;
(3) the serial number of product technical requirement;
(4) production date and duration of use or expiry date.
(5) product performance, main structure, the applicable scope;
(6), contraindications, precautions, and other needs warning or prompt content;
(7) installation and use instructions or graphic.
(eight) maintenance and maintenance method, special storage conditions, methods;
(9) other contents shall be marked as prescribed in the technical requirements.
The second class, the class iii medical devices shall also indicate the medical device registration certificate number and medical instruments the registrant's name, address and contact information.
Used by the consumers themselves for the safe use of medical devices shall also have special instructions.
Article 28 the production of medical apparatus and instruments, commissioned by the delegate to entrust production responsible for the quality of medical equipment.Entrusted party should be in accordance with these regulations, be equipped with the appropriate production conditions of the medical device manufacturing enterprise.The client shall strengthen the management of entrusted production behavior, ensure that in accordance with statutory requirements for production.
With high-risk medical planted instruments shall not entrust the production, the specific directory by the food and drug supervision and administration department under the state council, formulate, adjust and publish.

The fourth chapter medical equipment management and use

Article 29, are engaged in medical equipment operation should be adapted to business scale and business scope of the business premises and storage conditions, and the management of medical apparatus and instruments that meet the needs of quality management system and quality management organization or personnel.
Article 30 in the second category of medical equipment management, the business enterprise to the local districts municipal food and drug supervision and administration department of the people's government for the record and submit the information of the evidence of compliance with requirements specified in article 29 of the act.
Article 31, engaged in the management of the third class medical equipment management enterprise shall be reported to the local districts municipal food and drug supervision and administration department of the people's government to apply for business license and submit the information of the evidence of compliance with requirements specified in article 29 of the act.
Accepts the business license for the food and drug supervision and administration department shall within 30 working days from the date of acceptance of a review, organization for verification if necessary.To comply with the prescribed conditions, permission and given a medical equipment business licenses;Does not meet the prescribed conditions, no license and explain the reasons in written form.
Medical equipment business license is valid for five years.Need to continue to the expiration of the valid period of the law of administrative licensing in accordance with the relevant provisions of the procedure.
Article 32 medical equipment management enterprise, use the unit purchasing medical apparatus and instruments, shall examine the qualifications of the suppliers and qualified certificates for medical devices, build system of incoming inspection records.In the second, third class medical equipment wholesale business, and the third class medical appliance retail business enterprise, also should set up a sales record system.
Record matters including:
(a) the name of the medical instrument, model, specification and quantity;
(2) medical equipment production batch number, validity, date of sale;
(3) the name of the manufacturing enterprise;
(4) suppliers or buyers of the name, address and contact way;
(5) related to the licensed certificate no., etc.
Incoming inspection records and sales records shall be true, and in accordance with the time limit prescribed by the food and drug supervision and administration department under the state council shall be saved.The state encourages the use of advanced technology for recording.
Article 33 of the transportation and storage of medical equipment, it shall conform to the requirements of medical equipment manual and label;To temperature, humidity and other environmental conditions have special requirements, shall take appropriate measures to ensure the safety of medical equipment, effective.
Article 34 medical apparatus and instruments and the using unit shall have to use medical device type, quantity and conditions appropriate to the storage place.
Medical apparatus and instruments used units shall strengthen the technical training of staff, according to the product specification, technical operation standard requires the use of medical equipment, etc.
Article 35 medical devices use the unit for repeated use of medical devices, health family planning under the state council shall, in accordance with the stipulations on the management of disinfection and formulated by the competent department for processing.
Disposable medical devices shall not be repeated use, shall be destroyed in accordance with the relevant provisions of the state of used and record.
Article 36 of the medical equipment use the unit for regular inspection, testing, calibration, maintenance, maintenance of medical apparatus and instruments, shall be conducted in accordance with the requirements of the product manual inspection, testing, calibration, maintenance, maintenance and record, timely analysis, evaluation, ensure the medical equipment in good condition, ensure quality of use;For life long large medical equipment, should be established to use archives, record the actual use, transfer, operation and maintenance time.Records kept for use time limit prescribed by medical devices shall not be less than 5 years after the termination.
Article 37 of the medical equipment use the unit shall be properly kept buying class iii medical devices of the original data, and to ensure that information has the traceability.
Use of large medical apparatus and instruments, and implants and intervention of medical apparatus and instruments, medical apparatus and instruments shall be of the information such as name, key technical parameters and is closely related to the quality and safety of using the necessary information documented in the medical records and relevant records.
Article 38 found that use of the safety of medical equipment, medical apparatus and instruments used units shall immediately stop using, and inform the production enterprise or any other responsible for product quality inspection agency;After overhaul still cannot achieve use safety standards of medical devices, may not continue to use.
Article 39 the food and drug supervision and administration department and health department in charge of family planning according to their respective duties, respectively, on the use of link quality of medical equipment and medical instruments to supervise the use of behavior.
Article 40 medical equipment management enterprise, use the unit shall operate and use not in accordance with the registration certificate for qualified products, as well as the expired, failure, elimination of medical equipment.
Article 41 the medical apparatus and instruments use unit transfer between the medical apparatus and instruments, the assignor shall ensure that the transfer of medical equipment is safe, effective, shall not be transferred overdue, failure, selection and inspection unqualified medical instruments.
Article 42 of the imported medical instruments shall be in accordance with the provisions of chapter ii of these regulations have been registered or have the record of medical apparatus and instruments.
Imported medical instruments shall have a manual in Chinese, the Chinese label.Manual, label shall comply with these regulations and compulsory standards requirements, and the origin of medical apparatus and instruments as stated in the specification and the agent's name, address, contact information.There is no Chinese manual, Chinese label or instructions, labels, not in accordance with the provisions of this article, shall not be imported.
Article 43 the entry-exit inspection and quarantine institutions shall be inspected in accordance with the law of imported medical instruments;Inspection is unqualified, shall not be imported.
The food and drug supervision and administration department under the state council shall timely report to the national entry-exit inspection and quarantine authorities of import medical instrument registration and for the record.Import port the local entry-exit inspection and quarantine institutions shall promptly to the local districts municipal food and drug supervision and administration department of the people's government on the customs clearance of imported medical instruments.
Article 44 the export enterprise of medical devices shall guarantee that its exports of medical equipment in accordance with the requirements of the importing countries (regions).
Article 45 the advertisements of medical equipment should be true and legal, must not contain any false, exaggerated, misleading content.
Medical device advertisements shall be subject to the medical device production enterprise or the import medical equipment agent local people's governments of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department for examination and approval, the approval documents and medical equipment ads.Publishers, medical apparatus and instruments advertising should check in advance of the approval documents of the advertising and its authenticity;Shall not be released without the authenticity of the documents of approval, the approval document without checking or the contents of advertisements with the approval documents of medical apparatus and instruments.People's governments of provinces, autonomous regions and municipalities directly under the central government shall be announced by the food and drug supervision and administration department and update has been approved by the medical advertising directory and approved the contents of advertisements.
People's governments at or above the provincial level to the food and drug supervision and administration department shall be ordered to suspend the production, sale, import and use of medical devices, during the period of suspension shall not release the advertisements of medical devices.
Medical equipment advertising way to review by the food and drug supervision and administration department under the state council in conjunction with the administrative department for industry and commerce under the state council.

The fifth chapter recalls of dealing with medical devices adverse events

Article 46 the state shall establish a system of medical device adverse event monitoring, adverse events of medical devices for collection, analysis, evaluation and control in a timely manner.
Article 47 the medical device production enterprise, the use of units should have the production and business operation or use of medical device adverse event monitoring;Found that medical device adverse events or suspicious adverse events, shall be in accordance with the provisions of the food and drug supervision and administration department under the state council, report to the medical device adverse event monitoring technology institutions.
Any unit or individual to find medical devices adverse events or suspicious adverse events, have the right to food and drug supervision and administration department or the medical device adverse event monitoring technology agency report.
Article 48 the food and drug supervision and administration department under the state council shall strengthen the construction of medical device adverse event monitoring information network.
Medical device adverse event monitoring technology institutions should strengthen the medical device adverse event monitoring information, take the initiative to collect information about adverse events;Find adverse events or received adverse event reports, it shall timely verify, investigation, analysis, to evaluate adverse events, and to the food and drug supervision and administration department and health department in charge of family planning Suggestions to deal with.
Medical device adverse event monitoring technology institutions shall be announced by the contact way, convenient for medical device production enterprise, the use of units and other medical device adverse event report.
Article 49 the food and drug supervision and administration department shall take timely according to the results of the medical device adverse event evaluation issued warnings, and shall be ordered to suspend production, sale, import and use of control measures.
People's governments at or above the provincial level to the food and drug supervision and administration department shall, in conjunction with the departments of family planning and related departments for public health organizations at the same level as to the cause of sudden, mass medical device adverse event of serious injury or death to investigate and deal with in time, and organization of the same kind of medical equipment to strengthen monitoring.
Article 50 medical equipment production enterprise, use the unit shall be of medical device adverse event monitoring technology institutions, food and drug supervision and administration of medical devices adverse incident investigation and cooperate.
Article 51 any of the following circumstances, the people's governments at or above the provincial level of the food and drug supervision and administration department shall be registered medical equipment organization to carry out the evaluation:
(a) according to the development of science and research, the safety of medical equipment, effective cognitive change;
(2) medical device adverse event monitoring, evaluation results showed that the medical devices may be flawed;
(3) the food and drug supervision and administration department under the state council provisions of other require further evaluation.
Evaluation results show that the medical devices registered again cannot ensure safe, effective, by cancellation of the registration certificate of medical equipment, the original license issuing department and publish to the society.By cancellation of medical device registration certificate of medical devices shall not the production, import, management, use.
Article 52 medical device manufacturing enterprise found that the production of medical equipment do not conform to the compulsory standards, the product technical requirements for registration or registration or other defects, it shall immediately stop production, inform the related production and operation enterprises, the use of units and consumers to stop operation and use, recall has been on sale of medical apparatus and instruments, remedial, destruction, record related situation, release information, and will be treated as medical device recall and situation to the food and drug supervision and administration department and the health department in charge of family planning report.
Medical equipment management enterprise of its operating medical equipment are found in the preceding paragraph, it shall immediately stop operations, notify the relevant production and operation enterprises, the use of units and consumers, and record the stop operation and inform the situation.Medical device manufacturing enterprise that belongs to the medical apparatus and instruments of in accordance with the provisions of the preceding paragraph need to recall, shall immediately recall.
Medical device manufacturing enterprise is not in accordance with the provisions of this recall or stop operation, the food and drug supervision and administration department may order the recall or stop operating.

The sixth chapter supervision and inspection

Article 53 the food and drug supervision and administration department shall for registration, record of medical apparatus and instruments, production, management and use activities to strengthen the supervision and inspection, and focus on the supervision and inspection for the following items:
(a) whether the medical device manufacturing enterprise according to the product technical requirements for registration or registration organization production.
(2) whether the quality management system of medical device manufacturing enterprise keep effective operation;
(3) of the medical device manufacturing enterprise production and operation conditions of whether to continue to comply with legal requirements.
Article 54 the food and drug supervision and administration department in the supervision and inspection has the following functions and powers:
(a) enter the site implementation of inspection, sampling;
(2) review, reproduction, seal up, distrain the relevant contracts, bills, books and other relevant materials;
(3) the seizure, detainment is not in conformity with the statutory requirements of medical apparatus and instruments, illegal use of spare parts, raw materials and tool for the illegal production of medical equipment, equipment;
(4) seized in violation of the provisions of these regulations in medical equipment production and operation activities.
Food and drug supervision and administration department for supervision and inspection, shall produce law enforcement certificates, conservative commercial secrets of the units under inspection.
Units and individuals concerned shall be for the food and drug administration department of the supervision and inspection shall cooperate, relevant information shall not conceal.
Article 55 the cause harm to human body or there is evidence that may endanger human body health medical apparatus and instruments, food and drug supervision and administration department may take suspended the production, import, management, use of emergency control measures.
Article 56 the food and drug supervision and administration department should strengthen the medical device manufacturing enterprise production and management, and use the unit using random inspection of medical devices.Random inspection shall not charge inspection fee and any other fees, expenses into the government budget at the corresponding level.
People's governments at or above the provincial level the food and drug supervision and administration department shall, according to random inspection conclusion medical instrument quality announcement in a timely manner.
Article 57 medical equipment inspection agency qualification accreditation in accordance with the relevant provisions of the state exercises unified management.By the certification and accreditation supervision and administration department under the state council together with the food inspection agencies acknowledged by the pharmaceutical supervisory and administrative department, may conduct medical device test.
Food and drug supervision and administration departments of medical apparatus and instruments is needed in law enforcement inspection, shall entrust a qualified medical equipment inspection institutions, and pay the relevant expenses.
Party to object to the inspection conclusion, can the receipt within 7 working days from the date of inspection conclusion selecting medical equipment inspection institutions qualified for review.Review work of medical equipment inspection institutions shall, in the food and drug supervision and administration department under the state council within the stipulated time to make the re-inspection conclusion.The re-inspection conclusion for the final inspection.
Article 58 for possible harmful substances or unauthorised changes to the medical device design, raw materials and the safety of medical apparatus and instruments, production process and according to the regulations of the medical equipment national standards, industry standards of inspection items and test methods can't inspection, medical device testing institutions inspection can complement test items and test methods;Using complementary inspection items, inspection method of inspection conclusion, approved by the food and drug supervision and administration department under the state council, can be used as a food and drug supervision and administration department as the basis of medical device quality.
Article 59 municipal people's government at the county level and the food and drug supervision and administration department should strengthen the supervision and inspection of medical apparatus advertisements;Without approval, tampering with the approved medical equipment ads in advertising, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government shall be the food and drug supervision and administration department report, by its announced to the public.
Industrial and commercial administrative departments shall, in accordance with the provisions of the laws and administrative regulations on the management of advertising, advertising, conducting supervision and inspection of medical devices to investigate and punish the illegal behavior.Food and drug supervision and administration department found advertising illegal behavior, medical devices shall be handling Suggestions and handed over to local administrative department for industry and commerce at the same level shall, in accordance with the relevant program.
Article 60 the food and drug supervision and administration department under the state council shall establish a unified information platform of the supervision and administration of medical devices.Food and drug supervision and administration department shall, through the information platform released in a timely manner in accordance with the medical equipment permits, for the record, random inspection, such as illegal behavior investigation situation daily supervision and management information.However, may not disclose the commercial secrets of the parties.
The food and drug supervision and administration of medical apparatus and instruments registrant and for the record, the production and operation enterprises, use the unit to establish credit files, with the increase of bad credit supervision and inspection frequency.
Article sixty-one shall be announced by the food and drug supervision and administration departments such as the contact information of this unit, accept consulting, complaints and reports.The food and drug supervision and administration departments received inquiries related to the supervision and administration of medical devices, it shall timely reply;Received complaints and reports, it shall timely verify and for attention and reply.For consultation, complaints, reports, verification, processing conditions and reply, shall be recorded and saved.
On medical equipment development, production, management, use the report be true after investigation, the food and drug supervision and administration departments of individual reporting shall be rewarded.
Article sixty-two the food and drug supervision and administration department under the state council, formulate, adjust and modify the directory of these regulations and norms related to the supervision and administration of medical devices, shall be open for advice;To form such as panel discussion, feasibility study meeting, hearing to listen to experts, medical device manufacturing enterprise and use the unit, consumers, and the opinions of the relevant organizations and so on.

Chapter vii legal responsibility

Article sixty-three any of the following circumstances, the people's government at or above the county level shall the food and drug supervision and administration department shall have his unlawful income confiscated, the illegal production and operation of medical instrument and tool for the illegal production and operation, equipment, raw materials and other items;The illegal production and operation of medical instrument value of less than 10000 yuan, and be fined between RMB 50000 yuan and 50000 yuan;Value of 10000 yuan of above, and be fined value 10 times more than 20 times the following;If the circumstances are serious, not to accept the relevant responsible persons and enterprises within five years of medical equipment licensing applications:
(a) has not obtained in the production and operation of medical device registration certificate of the second and third class medical apparatus and instruments;
(2) without permission in the second, third class medical equipment production activities;
(3) without permission in the third class medical equipment business activities.
Is the first case of the preceding paragraph, if the circumstances are serious, medical device manufacturing license revoked by the original license issuing department or medical equipment business licenses.
Article sixty-four to provide false information or take other deception to obtain registration certificate of medical equipment, medical equipment production license, medical equipment business licenses, advertising and other documents of approval certificates, revoked certificates which have been obtained by the original license issuing department, and be fined between RMB 50000 yuan and 50000 yuan, five years not to accept the relevant responsible persons and enterprises apply for medical equipment licensing.
Forge, alter, buy and sell, lease or lend the relevant certificates of medical equipment, shall be confiscated by the original license issuing department or revoked, confiscate the illegal income;The illegal income of less than 10000 yuan, a fine of not more than 10000 yuan and 30000 yuan;The illegal income of 10000 yuan of above, in a fine three times more than five times the illegal income;ACTS violating the administration of public security, public security management punishment by the public security organs in accordance with the law.
Article sixty-five not in accordance with the provisions of these regulations, for the record, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to deadline to correct,Do not make the corrections within the time limit, announced to the public for the record unit and the product name, you can place a fine of less than RMB 10000.
At or above the county level shall, for the record to provide false information when the food and drug supervision and administration department of the people's government announced to the public for the record unit and the product name;If the circumstances are serious, the persons directly responsible shall not be engaged in medical equipment production and business operation activities within five years.
Article sixty-six any of the following circumstances, the people's government at or above the county level shall the food and drug supervision and administration department shall be ordered to correct, confiscate the illegal production, operation or use of medical apparatus and instruments;Illegal production, operation or use of medical value of less than 10000 yuan, and be fined between RMB 20000 yuan and 20000 yuan;Value of 10000 yuan of above, and be fined value 5 times more than 10 times the;If the circumstances are serious, order to suspend production or business operation, until revoked by the original license issuing department registration certificate of medical equipment, medical equipment production license, medical equipment business licenses:
(a) production, management, use do not conform to the compulsory standards or does not conform to the product technical requirements for registration or registration of medical apparatus and instruments;
(2) or not according to the medical device manufacturing enterprise registration for the record of the manufactured product technical requirements, or not in accordance with the provisions of these regulations, establish and maintain effective quality management system operation;
(3) management, using no qualified certificate, expired, failure, elimination of medical equipment, or use not lawfully registered medical apparatus and instruments;
(4) the food and drug supervision and administration department shall be ordered to recall according to these regulations or stop operation, still refused to recall or stop the operation of medical apparatus and instruments;
(5) entrusted enterprise production conditions are not available for the regulation of medical equipment, or manage the production behavior of the entrusted party.
Article sixty-seven any of the following circumstances, the people's government at or above the county level shall the food and drug supervision and administration department shall be ordered to correct, a fine of not more than 10000 yuan and 30000 yuan;If the circumstances are serious, order to suspend production or business operation, until revoked by the original license issuing department of medical equipment production license, medical equipment business licenses:
(a) of the medical device manufacturing enterprise production conditions change, no longer meet the demands of medical device quality management system, and not in accordance with the provisions of these regulations, the rectification, stop the production, the report;
(2) the production and business operations manual, label is not in conformity with the provisions of this ordinance of medical apparatus and instruments;
(3) is not in accordance with the requirements for medical equipment manual and label transportation, storage of medical apparatus and instruments;
(4) transfer date, failure, eliminate or test unqualified in medical instrument.
Article sixty-eight under any of the following circumstances, by the people's governments at or above the county level to the food and drug supervision and administration department and the health department in charge of family planning according to their respective duties shall be ordered to correct, given a warning;Refuses to correct, a fine of not more than 5000 yuan and 20000 yuan;If the circumstances are serious, order to suspend production or business operation, until revoked by the original license issuing department of medical equipment production license, medical equipment business licenses:
(a) medical device manufacturing enterprise are not submitted in accordance with the requirements of quality management system of inspection report;
(2) of the medical equipment management enterprise, use the unit not in accordance with the provisions of these regulations, establish and implement the system of medical equipment purchase inspection records;
(3) for the second, third class medical equipment wholesale business and the third class medical equipment retail business enterprise not in accordance with the provisions of these regulations, establish and implement the system of sales records;
(4) to the repeated use of medical equipment, medical equipment use the unit is not carried out in accordance with the stipulations on the management of disinfection and treatment;
(5) medical devices unit using repeated use of disposable medical devices, or destroy not according to stipulations used disposable medical apparatus and instruments;
(6) the need for regular inspection, testing, calibration, maintenance, maintenance of medical equipment, medical equipment unit using not in accordance with the requirements for product manual inspection, testing, calibration, maintenance, maintenance and record, timely analysis, evaluation, to ensure the medical equipment in good condition;
Unit (7) medical devices are not properly kept buying class iii medical devices of the original data, or not according to stipulations to large class medical devices and implants and interventional medical devices information record into the medical records and relevant records;
Unit (8) medical devices are found using medical equipment unsafe did not immediately stop using, notifications, repair, or continue to use after repair still cannot achieve use safety standards of medical apparatus and instruments;
(9) medical equipment production enterprise, use the unit is not in accordance with these regulations in medical device adverse event monitoring, did not report adverse events in accordance with the requirements, or for medical device adverse event monitoring technology institutions, food adverse events survey conducted by the pharmaceutical supervisory and administrative departments shall not be joined together.
Article sixty-nine in violation of the provisions of these regulations to carry out medical device clinical trials, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to correct or stop clinical trials, to a fine of less than RMB 50000;Thereby causing serious consequences, in accordance with the law, the person in charge directly responsible and other directly responsible personnel to demoted, dismissed or expelled sanction.A medical instrument clinical trial institution qualification, awarded by the certificate revoked by the competent department of medical instrument clinical trial institution qualification, not accept the application for qualification authentication within five years.
Medical instrument clinical trial institution issued a false report, by granting the certificate revoked by the competent department of medical instrument clinical trial institution qualification, 10 years does not accept the application for qualification authentication;By the people's governments at or above the county level to the food and drug supervision and administration department shall be imposed a penalty fine not exceeding 50000 yuan and 100000 yuan;Have the illegal income, confiscate the illegal income;The person in charge directly responsible and other directly responsible personnel, given sacked or kicked out of the sanctions in accordance with the law.
Article seventy of the medical device testing institutions to issue false inspection reports, by granting the certificate revoked by the competent department of the inspection certificate, 10 years does not accept the application for qualification authentication;A fine of less than RMB 100000 to 50000 yuan;Have the illegal income, confiscate the illegal income;The person in charge directly responsible and other directly responsible personnel, given sacked or kicked out of the sanctions according to law;Been expelled, since the date of disposal decision 10 years shall not be engaged in medical equipment inspection work.
Article seventy-one in violation of the provisions of these regulations, the advertisement has not obtained approval document of medical apparatus and instruments, prior to verify the authenticity of the documents of approval that advertise medical apparatus and instruments, or release the contents of advertisements with the approval documents of medical apparatus and instruments of advertising, the administrative department for industry and commerce in accordance with the provisions of the laws and administrative regulations on the management of advertising to give punishment.
Tampering with the approved medical apparatus and instruments of advertising, by canceling the original license issuing department of advertising approval documents of the medical equipment, two years not to accept the application for examination and approval of its advertising.
The issuing false advertising of medical equipment, by the people's governments at or above the provincial level food and drug supervision and administration department decided to suspend selling the medical apparatus and instruments, and publish to the society;Still selling the medical apparatus and instruments, the people's government at or above the county level shall confiscate the illegal sales of food and drug supervision and regulation department of medical equipment, and be fined between RMB 20000 yuan and 20000 yuan.
Article seventy-two of the medical instrument technical evaluation institutions, medical device adverse event monitoring technology institutions did not perform their duties according to these regulations, leading to a significant error in the review, monitoring work, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to correct, informed criticism, given a warning;Thereby causing serious consequences, the person in charge directly responsible and other directly responsible personnel, in accordance with the law to give demoted, dismissed or expelled.
Article seventy-three the food and drug supervision and administration departments and their staff shall strictly in accordance with the provisions of these regulations, amplitude, and the types of the punishment according to the circumstances of the nature of the illegal act and the specific exercise of administrative punishment, the specific measures shall be formulated by the food and drug supervision and administration department under the state council.
Article seventy-four in violation of the provisions of these regulations, the food and drug supervision and administration department of the people's government at or above the county level or other departments concerned fails to perform the supervision and administration of medical devices or abusing authority, dereliction of duty, practice favoritism, shall be appointed or removed by the supervisory organ or organ the person in charge directly responsible and other directly responsible personnel in accordance with the law to give warning, demerit recording or give punishment;Thereby causing serious consequences, a downgrade, dismissed or expelled.
Article seventy-five in violation of the provisions of these regulations, if the case constitutes a crime, shall be investigated for criminal responsibility according to law;Personal, property or other damage, assume liability to pay compensation in accordance with the law.

Chapter 8 is attached

Article seventy-six for the purposes of this act:
Medical apparatus and instruments, it is to point to directly or indirectly to the body's instrument, equipment, instruments, in vitro diagnostic reagents and calibration, materials, and other similar or related items, including computer software needed to;Its utility by physical methods such as get, not by way of pharmacology, immunology or metabolism, or despite these ways to participate in but only a supplementary role;The aim is to:
(a) disease diagnosis, prevention, care, treatment or ease;
(2) the damage diagnosis, monitoring, treatment, alleviate or functional compensation;
(3) the physical structure or physiological process of inspection, replacement, adjustment or support;
(4) support or sustain life;
(5) pregnancy control;
(6) through the inspection on samples from the body, to provide information for medical or diagnostic purposes.
Unit using medical devices "refers to the use of medical apparatus and instruments for others to provide medical and other technical services, including the practice license of medical institution of medical institutions, obtains the practice license of family planning technical service institution of family planning technical service institution, and don't need to be made in accordance with the practice license of medical institution of blood stations, stations of sole collection of plasma, rehabilitation equipment adaptation mechanism, etc.
Article seventy-seven the medical equipment product registration fees.The concrete charging items, standards respectively by the competent department of finance under the state council, the price set in accordance with the relevant provisions of the state.
Article seventy-eight nonprofit contraceptive measures for the management of medical equipment and medical and health institutions to deal with public health emergencies of the measures for the administration of medical devices by the food and drug supervision and administration department under the state council in conjunction with the departments of family planning of public health under the state council.
Measures for the administration of medical devices of traditional Chinese medicine by the food and drug supervision and administration department under the state council together with the management department of traditional Chinese medicine according to the provisions of these regulations;Rehabilitation auxiliary equipment category of medical equipment and management measures, by the food and drug supervision and administration department under the state council in conjunction with the civil affairs department under the state council formulated according to the provisions of these regulations.
The supervision and administration of the use of article seventy-nine of the military medical equipment, by the competent department of health according to relevant regulations, organizing the implementation of these regulations and the army.
Article eighty these regulations shall take effect on June 1, 2014.