Regulations on the supervision and management of medical device

(On January 4, 2000, the State Council of the People's Republic of China announced on the 39th Executive Meeting of the State Council on February 12, 2014. ） The decision of "revision)

Chapter 1 General Principles

Article 1 In order to ensure the safety of medical devices、Effective，Guarantee human health and life safety，Formulate these regulations。
Article 2 The development of medical devices in the People's Republic of China、Production、Business、Use activities and its supervision and management，It should abide by these regulations。
Article 3 The Food and Drug Supervision and Administration Department of the State Council is responsible for the supervision and management of national medical device。The relevant departments of the State Council are responsible for supervision and management related to medical equipment within their respective duties。
The food and drug supervision and management department of the local people's government at or above the county level is responsible for the supervision and management of medical device in the administrative area。The relevant departments of the local people's government at or above the county level are responsible for supervision and management related to medical device -related supervision and management。
The Food and Drug Supervision and Administration Department of the State Council shall cooperate with the relevant departments of the State Council，Implementation of the national medical device industry planning and policy。
4 The state implements classified management of medical devices in accordance with the degree of risk level。
The first category is low risk，Implementation of conventional management can ensure its safety、Effective medical equipment。
The second category has moderate risk，Need strict control management to ensure its safety、Effective medical equipment。
The third category is high risk，You need to take special measures strictly controlling management to ensure its safety、Effective medical equipment。
Evaluate the degree of risk of medical equipment，The expected purpose of medical device should be considered、Structural features、How to use and other factors。
The Food and Drug Supervision and Administration Department of the State Council is responsible for formulating the classification rules and classification directory of medical devices，Production according to medical equipment、Business、Use situation，Timely analyzes the risk changes of medical equipment、Evaluation，Adjust the classification directory。Formulate、Adjust the classification directory，It should be fully listened to the production and operation enterprise of medical equipment and the unit、Opinions of Industry Organization，and refer to the classification practice of international medical device。The classification of medical device classification shall be announced to the society。
Article 5 The development of medical devices shall follow safety、Principles of effective and saving。The country encourages the research and innovation of medical devices，Give play to the role of market mechanism，Promoting the promotion and application of new technologies of medical device，Promote the development of the medical device industry。
6 Medical device products shall meet the mandatory national standards of medical equipment; there is no mandatory national standard，It should meet the standard of compulsory industry industry。
The medical device directory used at one time is formulated by the State Council's Food and Drug Supervision and Administration Department in conjunction with the State Council's health and family planning department、Adjust and announce。Repeated use can guarantee safety、Effective medical equipment，Not included in the medical device directory that is not used in one -time use。Design、Production process、Repeated use after improvement of disinfection and sterilization technology can ensure safety、Effective medical equipment，The directory of the medical device that should be used for one -time use should be adjusted。
Article 7 The medical device industry organization shall strengthen industry self -discipline，Promoting the construction of the integrity system，Urgent enterprises to carry out production and operation activities in accordance with the law，Guide enterprises honest and trustworthy。

Chapter 2 Registration and File of Medical Device Products

Article 8 The first type of medical device implements product filing management，Category 2、The third type of medical device implements product registration management。
Article 9 of the first category of medical device product filing and application for the second category、The third type of medical device product registration，The following information should be submitted:
(1) Product risk analysis information;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation information;
(5) Product manual and label sample;
(6) The development of the product、Production related quality management system documents;
(7) Prove product safety、Other information required for valid。
Registered applicants for medical device、The recorder shall be responsible for the authenticity of the submitted information。
Article 10 The filing of the first category of medical device products，Submit the filing information to the food and drug supervision and management department of the municipal people's government in the place where the recorder is located。Where，Product inspection report can be the self -examination report of the recorder; clinical evaluation data does not include clinical trial reports，Can be through literature、Data obtained by clinical use of similar products proves the safety of the medical device、Effective information。
Exporting the first type of medical device in my country，The representative agencies established in my country or designated corporate legal persons in my country as agents，Submit the filing information and the recorder (region) of the state (region) of the State Council's Food and Drug Supervision and Administration of the State Council.。
The matters stated by the filing data change，Should change the filing to the original filing department。
Article 11 Apply for the registration of the second category of medical device products，Registered applicants shall be provinced to the location、Autonomous Region、The Food and Drug Supervision and Administration Department of the People's Government of the Municipal Municipality submits a registered application information。Apply for the registration of the third category of medical device products，Registered applicants shall submit registered application information to the Food and Drug Supervision and Administration Department of the State Council。
Export to the second category of export to my country、Overseas manufacturers of the third category of medical devices，The representative agencies established in my country or designated business legal persons in my country as agents，Submit registration application materials and registered applicants (regional) competent departments to the State Council's Food and Drug Supervision and Administration Department to allow the certification documents for the listing and sales of the medical device。
Category 2、The product inspection report in the third type of medical device product registration application information shall be the inspection report issued by the medical device inspection institution; the clinical evaluation data shall include clinical trial reports，But in accordance with the provisions of Article 17 of these regulations, except for medical device removal of clinical trials。
Article 12 The food and drug supervision and management department accepted by the registration application shall transfer the registration application information to the technical review agency within 3 working days from the date of acceptance。The technical review agency shall submit the review opinions to the food and drug supervision and management department after completing the technical review。
Article 13 The food and drug supervision and management department accepted the registration application shall make a decision within 20 working days from the date of receiving the review opinion。Valid requirements、Valid requirements，Alumnis registered and issued to medical device registration certificates; for for not meeting the requirements，No registered and written in writing。
The Food and Drug Supervision and Administration Department of the State Council is considering the need to verify the quality management system when organizing the technical review of imported medical equipment，It should organize the quality management system inspection technology institution to conduct a quality management system verification。
Article 14 The registered second category、The third category of medical device products，Its design、Raw material、Production process、Applicable range、Using method, such as substantial changes，It may affect the safety of the medical device、Effective，The registrant shall apply to the original registered department for changing the registration procedures;，It does not affect the safety of the medical device、Effective，The change of the change should be filed with the original registered department。
Article 15 The validity period of the registration certificate of the medical device is 5 years。The expiry of the validity period needs to be registered，It should submit an application to the original registered department 6 months before the expiry of 6 months to the validity period。
Except for the situation stipulated in paragraph 3，The food and drug supervision and management department that receives the application for continuing registration shall make a decision to continue before the expiration of the medical device registration certificate.。If the decision is not made after the deadline，deemed to be allowed to continue。
If there is one of the following circumstances, the registration will not be continued:
(1) The registrant does not submit an application for continuation within the prescribed period;
(2) The mandatory standard for medical equipment has been revised，Application for continuing the registered medical devices cannot meet new requirements;
(3) Medical equipment for the treatment of rare diseases and responding to emergency public health incidents，Not completing the matters stated by the medical device registration certificate within the specified period of time。
Article 16 The newly developed medical equipment that has not been included in the classification directory，Applicants can apply for product registration directly，You can also determine the product category in accordance with the classification rules and apply to the State Council's food and drug supervision and management department to confirm the category of the State Council.。
Apply for the registration of the third category of medical device products，The Food and Drug Supervision and Administration Department of the State Council shall determine the category in accordance with the degree of risk，The medical device aimed at registered medical devices was incorporated into the category catalog in time。Application category confirmation，The Food and Drug Supervision and Administration Department of the State Council shall determine the category of the medical device within 20 working days from the date of acceptance of the application and inform the applicant。
Article 17 The filing of the first category of medical device products，No clinical trials need to be performed。Apply for the second category、The third type of medical device product registration，Clinical trials should be conducted; but，There is one of the following situations，It can be exempted from clinical trials:
(1) The working mechanism is clear、Design setting，Mature production process，The clinical application of the same variety of medical devices that has been listed for many years without serious adverse events，It does not change the conventional use;
(2) It can prove the safety of the medical device through non -clinical evaluation、Valid;
(3) Analyze and evaluate the clinical trials of the same variety of medical devices or clinical use，Can prove the safety of the medical device、Effective。
The medical stake online sports bettingStake Sports Bettingdevice directory exempt from clinical trials is formulated by the State Council's Food and Drug Supervision and Administration Department、Adjust and announce。
Article 18 Carry out clinical trials of medical device，It should be in accordance with the requirements of the quality management specifications of clinical trials of medical device，Perform the clinical trial agencies with corresponding conditions，and the province where the clinical trial proposal is located、Autonomous Region、Food and Drug Supervision and Administration of the People's Government of the Municipality directly under the Central Government。The food and drug supervision and management departments receiving clinical trial filing shall notify the filing situation of the same level of food and drug supervision and management department and the competent health and family planning department of the clinical trial institution。
Medical Device Clinical Test Institutions Implementation Management。The conditions and filing management measures and clinical trial quality management specifications that medical device clinical trial institutions should have，The food and drug supervision and management department of the State Council will formulate and announce and announce it in conjunction with the State Council's health and family planning department。
Article 19 The third type of medical device for clinical trials has high risk for the human body，It should be approved by the Food and Drug Supervision and Administration of the State Council。Clinical trials The third type of medical device directory that has high risk of the human body is formulated by the State Council's Food and Drug Supervision and Management Department、Adjust and announce。
Approval of clinical trials of the Food and Drug Supervision and Administration of the State Council，Equipment for institutions that intend to undertake clinical trials of medical equipment、Conditions such as professionals，The degree of risk of the medical device，Clinical trial Implementation Plan，Comprehensive analysis of clinical benefits and risk comparative analysis reports。The clinical trials are allowed，It should be reported to the presence of clinical trials and the province of the clinical trial institution、Autonomous Region、The Food and Drug Supervision and Administration of the People's Government of the Municipality and the competent department of health and family planning。

Chapter 3 Medical Device Production

Article 20: engaged in medical device production activities，The following conditions should be possessed:
(1) Production venue that is compatible with the production of medical equipment、Environmental conditions、Production equipment and professional and technical personnel;
(2) Institutions or full -time inspectors and inspection equipment for the production of medical devices produced by production;
(3) The management system for ensuring the quality of medical equipment;
(4) After -sales service capacity to be adapted to the production of medical equipment;
(5) Product development、Requirements stipulated by the production process document。
Article 21 engaged in the production of first categories of medical equipment，The food and drug supervision and management department of the municipal people's government in the place where the manufacturer is located will be filed and submitted to the certification information that meets the requirements of Article 20 of these regulations。
Article 22 Entering the second category、The production of the third category of medical device，Production enterprises shall be provinced to the local area、Autonomous Region、The food and drug supervision and management department of the people's government of the municipality directly under the Central Government apply for production permits and submit it to the certification materials that meet the requirements of Article 20 of these regulations and the registration certificate of the medical device produced by Article 20。
The food and drug supervision and management department that accepts the application for production permit shall review the application information within 30 working days from the date of acceptance，Check it in accordance with the requirements of medical device production quality management specifications formulated by the Food and Drug Supervision and Administration Department of the State Council。For the prescribed conditions，Available permits and issued permits to medical device production permits;，No license and written explanation for the reason。
Production permit for medical equipment is valid for 5 years。The expiry of the validity period needs to be continued，Standards the continuation procedures in accordance with the laws and regulations on administrative licenses。
Article 23 The quality management specifications of medical device production shall be designed and developed for medical device、Production equipment conditions、Raw material procurement、Production process control、Enterprise institutional settings and personnel equipment affect medical equipment safety、Effective issues make clear stipulations。
Twenty -four medical device manufacturers shall be in accordance with the requirements of the quality management specifications of medical device production，Establish and improve the quality management system that is adapted to the medical equipment produced by it and ensure its effective operation;，Make sure that the medical equipment from the factory meets compulsory standards and registered or filed product technical requirements。
Medical device manufacturers should regularly check the operation of the quality management system，province to the location、Autonomous Region、The Food and Drug Supervision and Administration of the People's Government of the Municipal Municipality submits a self -examination report。
25 of the production conditions of medical device manufacturers changes，No longer meets the requirements of the medical equipment quality management system，Medical device manufacturers should immediately take rectification measures; it may affect medical equipment safety、Effective，Should stop production activities immediately，Report to the food and drug supervision and management department of the county -level people's government。
Article 26 of the medical device shall use a common name。The general name shall meet the medical device naming rules formulated by the Food and Drug Supervision and Administration Department of the State Council。
Article 27 The medical device shall have a manual、Tag。Manual、The content of the tag should be consistent with the relevant content of the registered or filing。
Manual for medical equipment、Tagged the following matters:
(1) General name, model, specification;
(2) The name and residence of the manufacturer、Production address and contact information;
(3) The number of product technical requirements;
(4) Production date and use period or failure date;
(5) Product performance, main structure, and scope of application;
(6) Contraindications、Note and other content that needs warning or prompts;
(7) Installation and use instructions or icons;
(8) Maintenance and maintenance method，Special storage conditions、Method;
(9) Other contents that should be marked by product technical requirements。
Category 2、The third category of medical devices should also indicate the name of the medical device registration certificate number and the name of the medical device registrar、Address and contact information。
Medical devices that consumers use their own self -use should also have a special explanation of safe use。
Article 28 Entrust the production of medical equipment，Responsible for the quality of the medical equipment commissioned by the commissioned party。The trustees shall comply with the provisions of these regulations、Medical Device Manufacturers with corresponding production conditions。The client shall strengthen the management of the production behavior of the trustee，Make sure it produces in accordance with statutory requirements。
High -risk implantable medical devices shall not be commissioned to produce，The specific directory is formulated by the Food and Drug Supervision and Administration Department of the State Council、Adjust and announce。

Chapter 4 Medical Device Operation and Use

Article 29 Entering medical device business activities，It should have business places and storage conditions that are compatible with the size and business scope of business，and the quality management system and quality management agency or personnel adapted to the operating medical equipment。
Article 30，The food and drug supervision and management department of the municipal -level people's government in the place where the business enterprise is located will record and submit it to the certification information of the conditions stipulated in Article 29 of these Regulations。
Article 31: engaged in the operation of the third category of medical equipment，The operating enterprise shall apply to the food and drug supervision and management department of the municipal people's government in the place where the local people's government is located, and submit it to the certification materials that meet the requirements of Article 29 of these regulations。
The food and drug supervision and management department applied for the application permit should be reviewed within 30 working days from the date of acceptance，Organize verification if necessary。For the prescribed conditions，Available permits and issued permits to medical device business;，No license and written explanation for the reason。
Medical Device Business License is valid for 5 years。The expiry of the validity period needs to be continued，Standards the continuation procedures in accordance with the laws and regulations on administrative licenses。
Article 32 of the medical device business enterprise、Use the unit to purchase medical equipment，The qualification document of the supplier and the qualified certificate of the medical equipment，Establish a purchase inspection record system。Entering the second category、The wholesale business of the third category of medical device and the business company of the third type of medical device retail business，It should also establish a sales record system。
Record matters include:
(1) The name of the medical device、Model、Specification、quantity;
(2) The production batch number of medical devices、Validity period、Sales date;
(3) The name of the manufacturer;
(4) The name of the supplier or buyer、address and contact information;
(5) Related license document number number, etc.
Purchase inspection records and sales records should be true，and save it in accordance with the deadline stipulated by the State Council's Food and Drug Supervision and Administration Department。The state encourages the use of advanced technical means to record。
Article 33 Transport、Storage medical equipment，It should meet the requirements of the medical device instructions and labels; for temperature、Special requirements for environmental conditions such as humidity，corresponding measures should be taken，Make sure the safety of medical equipment、Effective。
Article 34 The use of medical device use units shall be based on the use of medical device varieties、Storage venues and conditions that are suitable for quantity。Medical equipment use units shall strengthen technical training for staff，According to the product manual、Technical operation specifications and other medical equipment are required。
Medical Device Use Unit is equipped with large medical equipment，It should be in line with the large -scale medical equipment configuration plan set by the health and family planning department of the State Council，Positioning with its function、Clinical service needs are compatible，Have corresponding technical conditions、supporting facilities and corresponding qualifications、Professional and technical personnel with abilities，Approved by the health and family planning department of the people's government at or above the provincial level，Obtain a permit for the configuration of large medical equipment。
Management measures for the allocation of large medical equipment shall be formulated by the competent health and family planning department of the State Council and the relevant departments of the State Council。Large -scale medical equipment directory is proposed by the relevant department of the State Council of the State Council，After the approval of the State Council, execute。
Article 35 of the medical equipment use unit for reused medical equipment，It shall be treated in accordance with the provisions of disinfection and management formulated by the health and family planning department of the State Council。
Disposable medical devices shall not be reused，For those who have used it, they should be destroyed and recorded in accordance with relevant national regulations。
Article 36 The use of medical equipment use units need to be checked regularly、Test、Calibration、Maintenance、Maintenance medical equipment，Check it in accordance with the requirements of the product manual、Test、Calibration、Maintenance、Maintenance and record，Make analysis in time、Evaluation，Make sure that medical equipment is in a good state，Guarantee quality; large medical equipment with long period of use，Should be established on the stage，Record its use、Maintenance、Transfer、Actual use time and other matters。Record preservation period must not be less than 5 years after the period of termination of the use of medical devices。
Article 37 The use of medical device use units shall properly preserve the original information of purchasing the third type of medical device，and ensure that the information is traceable。
Using large medical devices and implants and intervention medical devices，The name of the medical device should be、Key technical Stake Sports BettingStake Sports Bettingparameters and other information, as well as the necessary information related to the use of quality and safety, record in related records such as medical records。
Article 38 The medical devices found to have hidden safety hazards，Medical equipment use units shall stop immediately，and notify the production enterprise or other institutions responsible for the quality of the product for maintenance; the medical device that can not reach the use of safety standards after inspection，Do not continue to use。
Article 39 of the Food and Drug Supervision and Administration Department and the competent department of health and family planning in accordance with their respective responsibilities，Supervise and manage the quality and use of medical equipment and medical equipment in the use link。
Article 40 Medical Device Business Enterprise、Use unit must not operate、Used unlimited registration、No qualified certification documents and expired、Lise、Medical equipment eliminated。
Article 41 Transfer of medical equipment，The transferor shall ensure the safety of the transferred medical equipment、Effective，Do not transfer expiration、Lise、elimination and unqualified medical equipment。
Article 42 of the imported medical devices shall be a medical device that has been registered or filing in accordance with the provisions of the second chapter of these regulations。
Imported medical devices should have a Chinese manual、Chinese label。Manual、Tags shall meet the requirements of these regulations and relevant compulsory standards，In the manual, the origin of the medical device and the name of the agent、Address、Contact information。No Chinese manual、Chinese label or instructions、Tags do not meet the stipulated in this article，Do not import。
Article 43: Entry -exit inspection and quarantine institutions are inspected and inspected imported medical devices in accordance with the law;，Do not import。
The Food and Drug Supervision and Administration of the State Council shall promptly notify the registration and filing of imported medical devices to the state entry and exit inspection and quarantine department。Exit -entry inspection and quarantine agencies where imported ports are located shall promptly report the customs clearance of imported medical devices to the food and drug supervision and management department of the municipal -level people's government in the area where they are located。
Article 44 Enterprises that export medical devices shall ensure that their exported medical devices meet the requirements of importing countries (regions)。
Article 45 of the medical device advertisement shall be true and legal，Do not contain false、Exaggeration、misleading content。
​​Medical Device Advertising should be provinces where medical device manufacturers or imported medical device agents are located、Autonomous Region、The Food and Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government is reviewed and approved，and get medical equipment advertising approval documents。Advertising publishers publish medical equipment advertisements，The approval documents and their authenticity of the advertisement should be checked in advance; it shall not be published for not obtaining the approval document、The authenticity of the approval file is not verified or the advertising content is inconsistent with the approval document.。Provincial、Autonomous Region、The food and drug supervision and management department of the people's government of the municipality directly under the Central Government shall announce and update the advertising catalog of the medical device and approved advertising content in a timely manner。
The food and drug supervision and management department of the people's government at or above the provincial level ordered the suspension of production、Sales、Imported and used medical devices，Advertisement involving the medical device shall not be published during the suspension period。
The review of medical equipment advertising shall be formulated by the State Council's Food and Drug Supervision and Administration Department in conjunction with the State Council's industrial and commercial administrative department。

Chapter 5 The treatment of bad events and the recall of medical equipment

Article 46 The monitoring system for the establishment of a bad event for medical device，Make a timely collection of bad events of medical equipment、Analysis、Evaluation、Control。
Article 47 of the production and operation enterprise of medical device、Use units shall monitor adverse events for medical devices that are produced or used;，shall be in accordance with the provisions of the food and drug supervision and management department of the State Council，Report to the Monitoring Technology Institutions of Medical Device Adverse Event Monitoring。
Any unit or individual discovered bad events or suspicious adverse events，It has the right to report to the food and drug supervision and management department or medical device adverse event monitoring technology institution。
Article 48 The Food and Drug Supervision and Administration Department of the State Council shall strengthen the construction of a medical device adverse event monitoring information network。
Medical Device Adverse Event Monitoring Technology Institutions shall strengthen information monitoring of adverse events of medical device，Actively collect non -performing events information; discovered that bad events or reports to adverse events，It should be verified in time、Investigation、Analysis，Evaluate bad events，and submit to the food and drug supervision and management department and the competent health family planning department to deal with it。
Medical Device Adverse Event Monitoring Technology Institutions shall publish contact information，Convenient for medical device production and operation enterprises、Reporting bad events in medical equipment。
Article 49 The food and drug supervision and administration department shall take the issuance of warning information in time according to the results of the evaluation of adverse events of the medical device、Sales、Import and use control measures。
The food and drug supervision and management department of the people's government at or above the provincial level shall, in conjunction with the competent department of health and family planning at the same level, organize an emergency、Severe damage or death of deaths in the group to investigate and deal with bad medical devices.，Organize the monitoring of similar medical equipment。
Article 50 of the production and business enterprise of medical device、Use unit shall be monitoring technology institutions for bad medical devices、The survey of adverse events carried out by the food and drug supervision and management department cooperate with the adverse incident of medical device。
Article 51 There is one of the following situations，The food and drug supervision and management department of the people's government at or above the provincial level shall re -evaluate the registered medical device organization:
(1) According to the development of scientific research，Safety of medical equipment、Effective changes in recognition;
(2) Monitoring of bad events of medical equipment、Assessment results indicate that there may be defects in medical devices;
(3) Other situations stipulated by the Food and Drug Supervision and Administration Department of the State Council。
Review results indicate that registered medical devices cannot guarantee safety、Effective，Logged out the medical device registration certificate from the original certificate department，and announce to the society。Medical devices that have been canceled in the medical device registration certificate shall not be produced、Import、Business、Use。
Article 52 Medical Device Production Enterprise found that the medical devices they produce do not meet the compulsory standards、Registered or filed product technical requirements or other defects，Should stop production immediately，Notification of related production and business enterprises、Use unit and consumers to stop operating and use，Recall medical equipment that has been listed on sale，Adopt remedy、Destruction and other measures，Record -related situation，Post related information，Report the recall and treatment of medical equipment to the food and drug supervision and management department and the competent health family planning department。
Medical device operating enterprises found that the medical device operated by the medical device has the stipulated situation specified in the preceding paragraph，It should stop operation immediately，Notification of related production and business enterprises、Use unit、Consumer，and record the stop operation and notification。Medical device manufacturers believe that it belongs to medical devices that need to be recalled in accordance with the provisions of the previous paragraphs，It should be recalled immediately。
Medical equipment production and operation enterprises have not implemented recalls or stop operations in accordance with the provisions of this Article，The food and drug supervision and management department may order it to recall or stop operation。

Chapter 6 Supervision and Inspection

Article 53 The food and drug supervision and management department shall register for medical equipment、Package、Production、Business、Use activities to strengthen supervision and inspection，and focus on the following matters:
(1) Whether medical device manufacturers are organized in accordance with registered or filing product technical requirements;
(2) Whether the quality management system of medical device manufacturers is effectively operated;
(3) Whether the production and operation conditions of medical device production and operation enterprises continue to meet legal requirements。
Article 54 The food and drug supervision and management department has the following powers in the supervision and inspection:
(1) Enter the on -site inspection and draw samples;
(2) Check、Copy、Seal、See related contracts、Bills、Accounts and other relevant information;
(3) Seal、Medical devices that are not met in accordance with statutory requirements，Components used illegal use、Raw materials and tools used in illegal production of medical equipment、Equipment;
(4) Seeing places that violate the production and operation activities of medical device in violation of these regulations。
Food and Drug Supervision and Management Department conducts supervision and inspection，The law enforcement certificate should be presented，Conservative business secrets of the inspection unit。
Relevant units and individuals shall cooperate with the supervision and inspection of the food and drug supervision and management department，Do not conceal the relevant situation。
55 medical device that causes damage to the human body or has evidence to prove that it may endanger human health，Food and Drug Supervision and Administration Department can take a suspension of production、Import、Business、Emergency control measures used。
Article 56 The food and drug supervision and management department shall strengthen the production of medical device production and operation enterprises and use units、Business、The spot check inspection of medical devices used。Spring inspection inspection shall not charge inspection fees and any other fees，The cost required for the government budget at this level。The food and drug supervision and management department of the people's government at or above the provincial level shall promptly issue the quality announcement of medical device quality in accordance。
The competent department of health and family planning shall supervise and evaluate the use of large medical equipment; discover illegal use and over -examination related to large medical equipment、Excessive treatment and other circumstances，It should be corrected immediately，Treatment according to law。
Article 57 The qualification identification work of the medical device inspection agency shall be implemented in accordance with relevant national regulations。The inspection agency identified by the State Council Certification and Certification and Certification Supervision and Management Department，Only by party can implement the medical equipment。
Food and Drug Supervision and Administration needs to test the medical device in law enforcement work，The qualified medical device inspection agency should be entrusted to conduct，and pay related fees。
The parties have objections to the conclusion of the inspection，You can choose a qualified medical device inspection institution within 7 working days from the date of receiving the test conclusion for re -inspection。The medical device inspection institution that undertakes the re -inspection work shall make a re -examination conclusion within the time stipulated by the State Council's food and drug supervision and management department。The conclusion of the re -examination is the final inspection conclusion。
Article 58 For the design of possible harmful substances or change the design of medical equipment without authorization、Medical equipment with raw materials and production processes and hidden safety hazards，According to the national standard of medical equipment、Inspection items and test methods specified in industry standards cannot be tested，The medical device inspection agency can supplement the inspection items and inspection methods for inspection; use the supplementary inspection item、Inspection conclusion obtained by testing methods，Approved by the State Council Food and Drug Supervision and Administration，It can be used as the basis for the quality of medical equipment for the quality of the food and drug supervision and management。
Article 59 The food and drug supervision and management departments of the municipal and county -level people's governments in the district shall strengthen the supervision and inspection of medical device advertising; it is found that it is not approved、Medical Device Advertising, admitted to the advertising content approved by the scriptures，It should be provided in the local area、Autonomous Region、Report on the Food and Drug Supervision and Administration of the People's Government of the Municipal People's stake online sports bettingGovernment，Announcement from the society。
Industrial and Commercial Administrative Management Department shall be in accordance with the law of advertising management、Regulations on administrative regulations，Supervision and inspection of medical equipment advertisements，Investigate and deal with illegal acts。Food and Drug Supervision and Administration Department found that medical device advertising illegal release behavior，It shall make a handling suggestion and transfer it in accordance with the relevant procedures.。
Article 60 The Food and Drug Supervision and Administration Department of the State Council establishes a unified medical device supervision and management information platform。The food and drug supervision and management department shall promptly publish medical equipment permits through the information platform、Package、Spring check inspection、Daily supervision and management information such as investigation and punishment of illegal acts。But，Do not leak the parties' business secrets。
Food and Drug Supervision and Administration Department of Medical Device Registers and Recorders、Production and operation enterprise、Use the unit to establish a credit file，Increased supervision and inspection frequency of bad credit records。
Article 61 Food, Drug Supervision and Management and other departments shall announce the contact information of the unit，Consultation、Complaint、Report。Food and Drug Supervision and Management and other departments received consultations related to medical device supervision and management，Should be answered in time; receive a complaint、Report，It should be verified in time、Treatment、Answer。Consultation、Complaint、Report situation and reply、A verification、Treatment，It should be recorded、Save。
Development of medical equipment、Production、Business、Reports using behavior are real，Food and Drug Supervision and Management and other departments should give rewards to the reporters。
Article 62 The Food and Drug Supervision and Administration Department of the State Council is formulated、Adjustment、Modify the directory stipulated in these regulations and specifications related to the supervision and management of medical device，It should be solicited publicly; adopting a hearing、Analysis Meeting and other forms，Listen to experts、Medical Devices production and operation enterprises and use units、Opinions from consumers and related organizations。

Chapter 7 Legal Responsibility

Article 63 There is one of the following situations，from the food and drug supervision and management department of the people's government at or above the county level confiscated illegal income、Medical devices that are illegal production and operation and tools used for illegal production and operation、Equipment、Raw materials and other items; illegal production and operation of medical device value of less than 10,000 yuan，Put a fine of 50,000 yuan and 100,000 yuan; with the value of the value of 10,000 yuan，and the value of the goods is more than 10 times the amount of more than 20 times the fine; if the circumstances are serious，Application of medical device permits proposed by the relevant responsible and enterprise within 5 years:
(1) Production、The second category of operating the registration certificate without obtaining medical device registration、The third category of medical equipment;
(2) Category of second category without permission、The third category of medical device production activities;
(3) For the third category of medical device business activities。
There is the first item of the previous paragraph、The serious plot，Frequent medical device production licenses or medical device business licenses in the primary certificate department。
Unauthorized configuration of large medical equipment，from the competent health and family planning department of the people's government at or above the county level or order to stop using，Give warning，Confession of illegal income; illegal income for less than 10,000 yuan，Putting fines of 10,000 yuan or less; illegal income for more than 10,000 yuan，Putting fined more than 5 times more than 10 times illegal income;，Application for the configuration permit of the large medical equipment proposed by the relevant responsible and units in 5 years。
144 Provide false information or take other deception methods to obtain medical device registration certificate、Production license for medical device、Medical Device Business License、Large -scale medical equipment configuration permit、Advertising approval documents and other licenses，The license that has been obtained from the original certificate department，Putting fines of 50,000 yuan and 100,000 yuan，Application of medical device permits proposed by the relevant responsible and units within 5 years。
Forgery、STC、Sale、rental、Out of the relevant medical equipment permit，It is collected or revoked by the original certificate department，Confession of illegal income; illegal income for less than 10,000 yuan，penalties for 10,000 yuan to 30,000 yuan; illegal income for more than 10,000 yuan，fines of more than 3 times illegal income or less;，Public security management punishment shall be punished by public security organs。
Article 65 If it is not filed in accordance with the provisions of these regulations，from the food and drug supervision and management department of the people's government at or above the county level or order to make corrections within a time limit;，Announced uncomfortable unit and product name to the society，can be fined less than 10,000 yuan。
Provide false information when filing，The food and drug supervision and management department of the people's government at or above the county level announces the filing unit and product name of the record for the society;，Direct responsible persons shall not engage in medical device production and operation activities within 5 years。
Article 66: One of the following situations，The food and drug supervision and management department of the people's government at or above the county level is ordered to make corrections，Confession of illegal production、Medical equipment operating or used; illegal production、The value of the medical device that is operated or used for less than 10,000 yuan，Packed of fines of 20,000 yuan and 50,000 yuan; the value of the value of the value of 10,000 yuan，and the value of the goods is 5 times more than 10 times the fine; if the circumstances are serious,，Order to stop production and stop business，until the certificate of medical device registration certificate was revoked by the original issuance department、Production license for medical device、Medical Device Business License:
(1) Production、Business、Use medical devices that do not meet the compulsory standards or do not meet the registered or filed product technical requirements;
(2) Medical device manufacturers have not organized production in accordance with the registered or filed product technical requirements，Or that the quality management system has not been established in accordance with the provisions of these regulations and maintains effective operation;
(3) Operation、Use no qualified certificate file、Expired、Lise、Medical equipment eliminated，or use medical devices that have not been registered in accordance with the law;
(4) The food and drug supervision and management department shall order it to implement the recall or stop operation in accordance with the provisions of these regulations，Still refused to recall or stop operating medical equipment;
​​(5) Entrusted enterprises to produce medical devices that do not have the conditions stipulated in these regulations，or if it has not been managed by the production behavior of the trustee。
Medical Device Business Enterprise、User's obligations such as the purchase inspection specified in these regulations，There is sufficient evidence to prove that they do not know what they are operating、Medical equipment used is the first paragraph of the previous paragraph、Medical equipment specified in the third paragraph of item，and can truthfully explain the source of its purchase，It can be exempted for punishment，But it should be confiscated according to law、The medical equipment used that does not meet the legal requirements。
Article 67 There is one of the following situations，The food and drug supervision and management department of the people's government at or above the county level is ordered to make corrections，penalties of 10,000 yuan to 30,000 yuan; if the circumstances are serious,，Order to stop production and stop business，Until the production license of the production of medical equipment was revoked by the primary certificate department、Medical Device Business License:
(1) The production conditions of medical device manufacturers have changed、No longer meets the requirements of the quality management system of medical equipment，No rectification in accordance with the provisions of these regulations、Stop production、Report;
(2) Production、Business Manual、The label does not comply with medical equipment stipulated in these regulations;
(3) No transportation is required in accordance with the medical equipment instructions and labels、Storage of medical equipment;
(4) Transfer expired、Lise、eliminated or inspected unqualified medical equipment。
Article 68 There is one of the following situations，The food and drug supervision and management department of the people's government at or above the county level and the competent health and family planning department ordered correction in accordance with their respective responsibilities，Give warning; refuse to correct，Published a fine of 5,000 yuan and 20,000 yuan; if the circumstances are serious,，Order to stop production and stop business，Until the production license of the production of medical equipment was revoked by the primary certificate department、Medical Device Business License:
(1) The medical device manufacturer fails to submit a self -inspection report of the quality management system as required;
(2) Medical device business enterprise、The use unit does not establish and executes medical device purchase inspection record system in accordance with the provisions of these regulations;
(3) Entering the second category、The wholesale business of the third type of medical device and the retail business of the third type of medical device's retail business did not establish and implement the sales record system in accordance with the provisions of these regulations;
(4) For reused medical equipment，The use unit of medical equipment is not processed in accordance with the regulations of disinfection and management;
(5) Repeated use of medical equipment for medical device use units，or medical devices that have not been used in accordance with the regulations;
(6) For regular inspections、Test、Calibration、Maintenance、Maintenance medical equipment，Medical Devices Used Unit did not check in accordance with the requirements of the product manual、Test、Calibration、Maintenance、Maintenance and record，Make analysis in time、Evaluation，Make sure that medical equipment is in a good state;
(7) Medical equipment use units have not properly preserved the original information for purchasing the third type of medical equipment，Or the information of large medical devices, as well as information on large medical devices, and interventional medical devices is recorded in related records such as medical records;
(8) Medical equipment found that medical devices found in medical device use units have no hidden safety hazards and did not stop using it immediately、Notification Maintenance，or continuing to use medical devices that can still not meet the safety standards that can not be used to use;
(9) Using large medical equipment，It cannot guarantee medical quality and safety;
(10) Medical equipment production and operation enterprise、Usage units are not monitored by adverse events in medical devices in accordance with the provisions of these regulations，Non -reporting adverse events as required，or Monitoring Technology Institution of Adverse Incidents for Medical Devices、Food and Drug Supervision and Administration Department's bad event survey is not cooperated。
Article 69 The clinical trials of medical devices in violation of these regulations，from the food and drug supervision and management department of the people's government at or above the county level or order to correct or stop clinical trials immediately，It can be fined less than 50,000 yuan;，Learn to be relegated to the person in charge and other directly responsible persons in accordance with the law、Remove or fired punishment; the agency shall not conduct clinical trials of related professional medical devices within 5 years。
The clinical trial institution of the medical device issued a false report，The food and drug supervision and management department of the people's government at or above the county level is fined 50,000 yuan or more than 100,000 yuan;，confiscation of illegal income;，A punishment for removal or firing in accordance with the law; the agency shall not conduct clinical trials of relevant professional medical devices within 10 years。
Seventy -10 medical device inspection agencies issued false inspection reports，The competent authority granting its qualification department revokes the inspection qualification，Application for qualification identification will not be accepted in 10 years; fines of 50,000 yuan or less;，confiscation of illegal income;，Gives dismissal or fired punishment in accordance with the law;，Failure to engage in medical device inspection work within 10 years from the date of the decision of the punishment。
Article 71 violates the provisions of these regulations，Published medical device advertisements that have not obtained approved documents，The authenticity of the approved documents without pre -verification, that is, the release of medical device advertisements，or publishing medical device advertisements with inconsistencies and approval documents，The administrative department of industrial and commercial administration in accordance with the law of advertising management、Punishment of administrative regulations。
Tampered with the advertising content approved by the Classics，Advertising approved documents for the medical device for the original certificate department，Not accepting its advertising approval application。
Introduce the advertisement of false medical device advertisements，The food and drug supervision and management department of the people's government at or above the provincial level decides to suspend the sale of the medical equipment，and announced it to the society; still sells the medical equipment，from the food and drug supervision and management department of the people's government at or above the county level, the medical device of illegal stake sports betting appsales is confiscated，Putting fines of 20,000 yuan and 50,000 yuan。
Article 72 of the medical device technology review agency、Medical Device Adverse Event Monitoring Technology Institutions Failure to fulfill their duties in accordance with the provisions of these regulations，To the review、Monitoring work in major mistakes，The food and drug supervision and management department of the people's government at or above the county level is ordered to make corrections，Report criticism，Give warning; cause serious consequences，For direct responsible persons and other direct responsible persons，Give relegation according to law、Remove or fired punishment。
Article 73 Food and Drug Supervision and Administration、The competent department of health and family planning and their staff shall strictly strictly in accordance with the types and amplitude of the penalty in accordance with the provisions of these regulations，Exercise the right to administrative punishment according to the nature of illegal acts and specific circumstances，Specific measures will be by the Food and Drug Supervision and Administration Department of the State Council、The competent department of health and family planning is formulated in accordance with their respective responsibilities。
Article 74 violates the provisions of these regulations，The food and drug supervision and management department of the people's government at or above the county level or other relevant departments does not perform the responsibilities of medical device supervision or abuse of authority、Attention、徇 徇，The supervisory organs or appointment and removal agencies give warnings to the directors and other direct responsible persons in accordance with the law、Remember or remembers a sanction; cause serious consequences，Give a downgrade、Remove or fired punishment。
Article 75 violates the provisions of these regulations，For the crime，Criminal responsibility in accordance with the law; cause personal、property or other damage，Bersed compensation liability in accordance with the law。

Chapter 8 Attachment

Article 76 The meaning of the following terms in these regulations:
Medical Device，refers to the instrument used directly or indirectly for the human body、Equipment、Equipment、In vitro diagnostic reagents and calibrations、Materials and other similar or related items，Including the required computer software; its utility is mainly obtained through physical and other methods，Not through pharmacology、Immunology or metabolic methods，or although there are these ways to participate, it only plays an auxiliary role; its purpose is:
(1) Diagnosis of the disease、Prevention、Monitoring、Treatment or relief;
(2) Diagnosis of damage、Monitoring、Treatment、relieving or functional compensation;
(3) Test of the physiological structure or physiological process、Replacement、Adjust or support;
(4) The support or maintenance of life;
(V) Pregnancy control;
(6) Check the samples from the human body，Provide information for the purpose of medical or diagnosis。
Medical Device Usage Unit，refers to an institution using medical devices to provide medical services such as medical services，Including medical institutions that obtain a medical institution's practice permit，Family planning technology service agency obtained by obtaining a practice permit for family planning technology service institutions，Blood station that does not need to obtain a license to obtain a medical institution in accordance with the law、Single Plasma Station、Rehabilitation Auxiliary Instrument Adaptering Institution, etc.。
Large medical equipment，refers to the complex use of technology、Large amount of capital investment、High running cost、Large medical devices that have a large impact on medical expenses and are included in directory management。
Article 77 can be charged for registration of medical device products。Specific charging items、Standards by the State Council Finance、The competent price authorities are formulated in accordance with relevant national regulations。
Article 78 The Administrative Measures for Non -profit Medical Devices and Medical and Health Institutions The Administrative Measures for Medical Device developed by medical and health institutions to deal with emergencies，Formulated by the State Council's Food and Drug Supervision and Administration Department in conjunction with the State Council's Health and Family Planning Department。
Administrative measures for traditional Chinese medicine medical equipment，The Food and Drug Supervision and Administration Department of the State Council, in conjunction with the State Council's Chinese Medicine Management Department in accordance with the provisions of these regulations;，The Food and Drug Supervision and Administration Department of the State Council, in conjunction with the Civil Affairs Department of the State Council, formulated in accordance with the provisions of these regulations。
Supervision and Management of the use of military equipment for military medical devices，Organized by the competent department of the army in accordance with these regulations and the relevant regulations of the army。
Article 80 These regulations shall be implemented from June 1, 2014。