(July 30, 2014 The State Food and Drug Administration Order No. 8 announced on November 7, 2017.
Chapter 1 General Principles
Article 1 In order to strengthen the supervision and management of medical device operations，Standardize medical device business behavior，Guarantee medical equipment safety、Effective，According to the "Regulations on the Supervision and Administration of Medical Devices"，Formation of these Measures。
Article 2 Entering medical device business activities and supervision and management in the People's Republic of China，It should abide by these Measures。
Article 3 The State Administration of Food and Drug Administration is responsible for national medical device operation supervision and management。Food and drug supervision and management department at or above the county level is responsible for medical device operation supervision and management in the administrative area。
The superior food and drug supervision and management department is responsible for guiding and supervising lower -level food and drug supervision and management departments to carry out medical device operation supervision and management。
Article 4: According to the degree of risk of medical equipment，Classification management of medical device operations。
Do not need permits and filing for operating first categories of medical devices，Management management of the second category of medical devices，Management of licensed management of the third category of medical devices。
5 The State Administration of Food and Drug Administration formulates the quality management specifications of medical device operations and supervision and implementation。
1 The sixth food and drug supervision and management department promptly publish medical device business license and filing information。Applicants can inquire about the approval progress and approval results，The public can check the approval results。
Chapter 2 Business License and File Management
7 Entering medical device operation，The following conditions shall be available:
(1) Quality management agencies or quality managers that are compatible with the scope of business and business，Quality management personnel shall have relevant professional education or titles recognized by the state;
(2) Operations that are compatible with the scope of business and business、Storage venue;
(3) Storage conditions that are compatible with the scope of business and business，All commissioned other medical device operating enterprises can store warehouses without setting up;
(4) Quality management system that is adapted to operating medical devices;
(5) Professional guidance that is adapted to medical devices with business、The ability of technical training and after -sales service，or agreed to provide technical support by relevant agencies。
Enterprises engaged in the third category of medical device operations shall also have a computer information management system that meets the quality management requirements of medical device operations，Metal available products that can be traced back。Encourage the first category、Enterprises operating in the second type of medical device establishes a computer information management system that meets the quality management requirements of medical device operations。
Article 8 of the third type of medical device operation，The operating enterprise shall apply to the municipal food and drug supervision and management department where the locations are located，and submit the following information:
(1) A copy of the business license;
(2) Legal representative、The person in charge of the enterprise、The identity certificate of the person in charge of quality、Locomotive or professional title certificate;
(3) Organization and department setting instructions;
(4) Operation scope and business way description;
(5) Operating venue、Geographical location of the address of the warehouse、Plane Figure、Housing property right certification documents or lease agreements (attached house property right certification documents) copies;
(6) Business facilities and equipment directory;
(7) Business quality management system、Working program and other file directory;
(8) The basic situation and function description of the computer information management system;
(9) The authorized certificate of the manager;
(10) Other proof materials.
1: Application for the third category of medical device operations proposed by the applicant，Municipal food and drug supervision and management departments of the district shall be processed according to the following situations:
(1) The application is its scope of power，Application information is complete、Following the legal form，The application should be accepted;
(2) Application materials are incomplete or not in line with legal forms，Should be informed of all the contents that the applicant needs to be corrected within 5 working days，If the overdue is not notified，It will be accepted since the date of receiving the application information;
(3) The existence of the application information can be correct on the spot，The applicant should be allowed to correct on the spot;
(4) The application matters do not belong to the scope of the head of the headquarters，Should make decisions that are not accepted immediately，and inform the applicant to apply to the relevant administrative department。
The city -level food and drug supervision and management department of the district is accepted or does not accept the application of medical device business permits，Notice of acceptance or not accepted。
Article 10 The municipal food and drug supervision and management department in the district shall review the application information within 30 working days from the date of acceptance，and conduct on -site inspections in My stake betting appaccordance with the requirements of the quality management specifications of medical device operations。It needs to be rectified，Rectification time is not included in the review time limit。
with prescribed conditions，Make a written decision permitted in accordance with the law，and issued the "Medical Device Business License" within 10 working days;，Make a written decision without license，Explain the reason。
Article 11 Application for medical device business permits stake sports betting appdirectly involves the major interest relationship between applicants and others，Food and Drug Supervision and Administration Department shall inform the applicant、Persons in the interest relationship in accordance with the law、Regulations and the relevant provisions of the State Food and Drug Administration enjoy the right to apply for hearing;，The food and drug supervision and management department believes that major license items involving public interests，It should be announced to the society，Hold a hearing。
Article 12，The operating enterprise shall record the municipal food and drug supervision and management department in the place where the placement area is located，Fill in the second type of medical device operation filing form，and submit the information stipulated in Article 8 (except)。
Article 13 The food and drug supervision and management department shall check the integrity of the information submitted by the enterprise on the spot，Focusing in compliance with regulations，Send to the second category of medical device operation filing vouchers。
Article 14 Municipal food and drug supervision and management departments in districts shall be within 3 months from the date of filing of medical device business enterprises，In My stake betting appaccordance with the requirements of medical device business quality management specifications, conduct on -site inspections of medical device business enterprises。
Article 15 "Medical Device Business License" is valid for 5 years，Delive the license number、Corporate name、Legal representative、The person in charge of the enterprise、Residence、Business scope、Business method、Business scope、Library address、issuance department、Date of issuance and validity period。
Medical Devices Business Management Certificate shall be contained in the number、Corporate name、Legal representative、The person in charge of the enterprise、Residence、Business scope、Business method、Business scope、Library address、The filing department、Date of filing。
Article 16 The change of the "Medical Devices Business License" matters are divided into change and registration of registration。
The change of the license items includes the place of business、Business method、Business scope、Change of the address of the warehouse。
The change of registration is the change of other matters other than the above items。
Article 17 The change of permission，The application for changes in the "Medical Devices Business License" shall be submitted to the original certificate department，and submitted the relevant information involved in the provisions of Article 8 of these Measures。
Set up warehouses in cross -administrative areas，The municipal food and drug supervision and management department in the place where the warehouse is located should be registered for filing。
The original certificate department shall review it within 15 working days from the date of receipt of the change application，and make a decision to change or not be changed; it is necessary to carry out on -site verification in My stake betting appaccordance with the requirements of the quality management specifications of medical device operations，Decisions for changes or not to change within 30 working days from the date of receipt of the change application。No change，It should be explained in writing and inform the applicant。The number and validity period of the "Medical Device Business License" after the change is unchanged。
Article 18 of the newly established independent operating place，Should apply for a separate medical device business license or filing。
Article 19 The registration items change，Medical device business enterprises shall promptly go through the municipal food and drug supervision and management department in the district to change the formalities。
Article 20 due to separation、Medical device business enterprise with merging and existence，It shall apply for a change permit in accordance with the provisions of these Measures; due to the separation of the enterprise、merged and dissolved，Should apply for cancellation of the "Medical Device Business License"; due to the separation of enterprises、Newly established，shall apply for the "Medical Device Business License"。
Twenty -one registrar of medical device、The recorder or the manufacturer sells medical devices in its residence or production address，No need to apply for business permits or filing; store in other places and sell medical devices in other places，It shall apply for business license or filing in accordance with regulations。
Article 22 "Medical Devices Business License" is valid for the expiry of the expiry date of，Medical device business enterprises shall be 6 months before the validity period，Specify the "Medical Device Business License" to the original certificate department for continuation application。
The original certificate department shall review the application for continuation in accordance with Article 10 of these Measures,On -site verification if necessary，Decisions for whether to continue before the expiration of the "Medical Device Business License"。with prescribed conditions，Quasible for continuation，The number of "Medical Device Business License" after the continuity is unchanged。If the prescribed conditions are not met，Order to be rectified within a time limit; if the rectification still does not meet the prescribed conditions，No continuation，Reasons to explain in writing。If the decision is not made after the deadline，It is deemed to be allowed to continue。
Article 23 The name of the enterprise in the medical device business filing voucher、Legal representative、The person in charge of the enterprise、Residence、Business scope、Business method、Business scope、The records of the warehouse address have changed，Should change the filing in time。
Article 24 The Lost of the "Medical Device Business License"，Medical device business enterprises shall immediately board the lost statement on the media designated by the original certificate department。One month after the loss of the lost statement，Apply to the original certificate department for reissue。The original certificate department has timely supplemented the "Medical Device Business License"。
The "Medical Devices Business License" number and validity period of the "Medical Devices Business License" are consistent with the original certificate。
Article 25 of the medical device operation filing certificate is lost，Medical device business enterprises shall promptly go through the procedures for the original filing department。
Article 26 The medical device operating enterprise has been investigated by the food and drug supervision and management department for investigation due to illegal operation.，or I received an administrative penalty decision but not yet fulfilled，Municipal food and drug supervision and management departments of the district should be suspended as the permit，until the case is handled。
Article 27 The medical device operating enterprise has laws、Regulations stipulates the situation that should be canceled，or the validity period is not full, but the company actively proposes to cancel，Municipal food and drug supervision and management departments of the district shall cancel its "Medical Device Business License"，and announced it on the website。
Article 28 The municipal food and drug supervision and management departments of the district shall establish a "medical device business license" issuance、Continuous、Change、Replenishment、Rejuvenation、Licensing files such as cancellation and such as medical device business filing information file。
Article 29 Any unit or individual shall not forge、STC、Sale、rental、Dedicated "Medical Devices Business License" and medical device business filing vouchers。
Chapter 3 Business Quality Management
Article 30 Medical device business enterprises shall be in My stake betting appaccordance with the requirements of medical device business quality management specifications，Establish a management system for the entire process of cover quality management，and do related records，Guarantee operating conditions and operating behavior continues to meet the requirements。
Article 31 of the medical device business enterprise assumes legal liability for the purchase and sale of medical device in the name of the company or sales personnel。Medical Device Operating Enterprise Sales Staff Sales Medical Device，The authorization letter of the official seal of the company should be provided。The authorized letter shall stimulate the variety of authorized sales、Region、Term，indicate the ID number of the sales staff。
Article 32 of the medical device business enterprise shall establish and execute the purchase inspection record system。Entering the second category、The wholesale business of the third category of medical device and the third type of medical device retail business shall establish a sales record system。Purchase inspection records and sales record information should be true、Accurate、Full。
Enterprises engaged in the wholesale business of medical device，Its purchase、Storage、Sales and other records shall meet the retrospective requirements。
Purchase inspection records and sales records should be stored to 2 years after the validity period of the medical device;，No less than 5 years。Investigation records and sales records of implanted medical device should be kept permanently。
Encourage other medical device business enterprises to establish a sales record system。
Article 33 of the medical device business enterprise shall purchase medical equipment from qualified manufacturers or operating enterprises。
Medical device operating enterprises shall agreed with the supplier for quality responsibilities and after -sales service liability，Ensure that medical device after -sales safe use。
It is responsible for the product installation with the supplier or the corresponding agency、Repair、Medical device business enterprises for technical training services，It is possible to set up departments that are not engaged in technical training and after -sales service，But there should be corresponding managers。
Article 34 of the medical device business enterprise shall take effective measures，Make sure medical equipment transportation、The storage process meets the medical device instructions or label label requirements，and make the corresponding record，Make sure the quality and safety of medical equipment。
Manual and label label requires low temperature、refrigerated，shall be in accordance with relevant regulations，Use low temperature、Refueling facilities and equipment transportation and storage。
Article 35 of the medical device operating enterprise entrusted other units to transport medical equipment，Evaluation and evaluation of the quality assurance capacity of the transportation party transportation medical equipment，Clarify the quality responsibility in the transportation，Make sure the quality and safety during transportation。
Article 36 of the medical device business enterprise provides storage for other medical equipment production and operation enterprises、Delivery service，Should sign a written agreement with the client，Clarify the rights and obligations of both parties，and have equipment and facilities that are compatible with product storage and distribution conditions and scale，The computer information management platform and technical means with real -time electronic data exchange with the commissioner and realize the entire process of product operation。
Article 37 The business enterprises engaged in the wholesale business of medical device shall be sold to qualified business enterprises or use units。
Article 38 of the medical device business enterprise shall be equipped with full -time or part -time personnel responsible for after -sales management，The quality of the customer's complaint should be found out，Take effective measures to deal with and feedback in time，and make a record，If necessary, the supplier and medical equipment production enterprise shall be notified。
Article 39 of the medical device business enterprise does not have the original operating license conditions or does not meet the filing information and cannot be contacted，After the primary certificate or the filing department is announced，Log canceling the "Medical Device Business License" in accordance with the law or marked in the second category of medical device operation filing information，Announcement to the society。
Article 40 The third type of medical device business enterprise shall establish a quality management self -inspection system，and in My stake betting appaccordance with the requirements of medical device business quality management specifications, conduct a whole project self -check，Submit an annual self -check report to the city -level food and drug supervision and management department in the place where the place where you are located at the end of each year。
Article 41: Third Category of Medical Device Operation Enterprise Stopping for more than one year，When re -operating，The municipal food and drug supervision and management department of the place where the local area is located in advance should be reported in advance，After the verification meets the requirements, the operation can be restored。
Article 42: Medical device operating enterprises shall not operate unregistered or filing、No qualified certification documents and expired、Lise、The eliminated medical equipment。
Article 43 of the medical device operating enterprise operating a major quality accidents occurred，Should be reported to the location of the place where the place is within 24 hours、Autonomous Region、Food and Drug Supervision and Management Department of Municipality directly under the Central Government，Provincial、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall immediately report to the State Food and Drug Administration。
Chapter 4 Supervision and Management
Article 44 The food and drug supervision and administration department shall supervise and inspect the situation of medical device operations in My stake betting appaccordance with the requirements of operating quality management specifications，Supervise enterprises to regulate business activities。For the third type of medical device business enterprises, the annual self -examination report for self -examination in accordance with the requirements of medical device operation quality management specifications，Examiners should be performed，On -site verification if necessary。
Article 45 province、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government shall compile the supervision and inspection plan of medical device business enterprises in the administrative area，and supervise the implementation。Municipal food and drug supervision and management departments in the district shall formulate the supervision focus of medical device business enterprises in their own administrative regions、Check the frequency and coverage rate，Organize implementation。
Article 46 The food and drug supervision and management department organizes supervision and inspection，Inspection plan should be formulated，My stake betting appClear inspection standard，Record the on -site inspection situation，Inform the inspection company。It needs to be rectified，It should be clearly clarified and the rectification period should be clear，Implementing tracking inspections。
Article 47 The food and drug supervision and management department shall strengthen the spot check and inspection of medical equipment。
Food and drug supervision and management departments above the provincial level shall promptly issue medical device quality announcements in accordance。
Article 48 There is one of the following situations，Food and Drug Supervision and Administration Department shall strengthen on -site inspections:
(1) There are serious problems in the supervision and inspection of the previous year;
(2) Violation of relevant laws、Regulations are punished by administrative penalties;
(3) The new third category of medical device business enterprises;
(4) The food and drug supervision and management department believes that other circumstances that need to be inspected on -site。
Article 49 The food and drug supervision and management department shall establish a daily supervision and management system for medical device operations，Strengthen the daily supervision and inspection of medical device business enterprises。
Article 50 of the reporting of complaints or other information display, and daily supervision and inspection found that there may be medical device business enterprises with hidden dangers of product safety，or medical device business enterprises with bad behavior records，Food and Drug Supervision and Management Department can implement flight inspections。
Article 51 There is one of the following situations，Food and Drug Supervision and Management Department may interview the legal representative or person in charge of medical device business enterprises:
(1) There are serious safety hazards in operations;
(2) The operating product was reported to complaints or media exposure due to quality problems;
(3) The credit rating is evaluated as a bad credit enterprise;
(4) The food and drug supervision and management department believes that it is necessary to carry out other circumstances for responsibility interviews。
Article 52 The food and drug supervision and management department shall establish a medical device business enterprise supervision file，Record license and filing information、Results of daily supervision and inspection、Investigation and punishment of illegal behavior，also implemented key supervision of medical device business enterprises with bad credit records。
Chapter 5 Legal Responsibility
Article 53 There is one of the following situations，Food and drug supervision and management department at or above the county level ordered to correct the time limit，Give warning; refuse to correct，Fined fines of 5,000 yuan or less than 20,000 yuan:
(1) Medical device business enterprises have not changed registration matters in accordance with the provisions of these Measures;
(2) Medical device operating enterprises send sales staff to sell medical equipment，If the authorized letter is not provided in My stake betting appaccordance with the requirements of these Measures;
(3) The third category of medical device business enterprises did not submit an annual self -examination report to the food and drug supervision department before the end of each year。
Article 54 There is one of the following situations，The food and drug supervision and management department at or above the county level is ordered to make corrections，Fined fines of 10,000 yuan and less than 30,000 yuan:
(1) The operating conditions of the business enterprise of medical device changes，No longer meets the requirements of the quality management specifications of medical device business，If the rectification is not rectified in accordance with regulations;
(2) Medical device business enterprise changes the operating place or the address of the warehouse、Expand the scope of business or set up warehouses without authorization;
(3) The operating enterprise engaged in the wholesale business engaged in the medical device sells to a non -qualified business enterprise or use unit;
(4) Medical device business enterprises never have qualified production、Operating an enterprise to purchase medical equipment。
Article 55，or "Medical Device Business License" has not been handled in accordance with the law after the expiration period expires、Still continuing to engage in medical equipment operation，Punishment in accordance with Article 63 of the Regulations on the Supervision and Administration of Medical Devices。
Article 56 Provide false information or take other deception methods to obtain the "Medical Device Business License"，Punishment shall be punished in accordance with Article 64 of the Regulations on the Supervision and Administration of Medical Devices。
Article 57 Forge、STC、Sale、rental、Dedicated "Medical Device Business License"，Punishment shall be punished in accordance with Article 64 of the Regulations on the Supervision and Administration of Medical Devices。
Forgery、STC、Sale、rental、Discipline of medical device operation filing vouchers，The food and drug supervision and management department at or above the county level is ordered to make corrections，Fined fines below 10,000 yuan。
Article 58: False information is provided when the filing or filing is not provided in accordance with the provisions of these Measures，Punishment in accordance with Article 65 of the Regulations on the Supervision and Administration of Medical Devices。
Article 59 There is one of the following situations，Food and drug supervision and management department at or above the county level ordered to correct the time limit，and punish in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices:
(1) Operations do not meet the compulsory standards or do not meet the registered or recorded product technical equipment;
(2) Operation without qualified certification documents、Expired、Lise、Medical equipment eliminated;
(3) After the food and drug supervision and management department is ordered to stop operation，Still refused to stop operating medical equipment。
Article 60 There is one of the following situations，The food and drug supervision and management department at or above the county level is ordered to make corrections，and punish in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices:
(1) Manual of the medical equipment operated、Tags do not meet the relevant regulations;
(II) No transportation is required in accordance with the medical equipment instructions and labels、Storage of medical equipment。
Article 61 There is one of the following situations，The food and drug supervision and management department at or above the county level is ordered to make corrections，and Article 68 of the Regulations on the Supervision and Administration of Medical Device:
(1) The operating enterprise has not established and implemented a check -up record system for the purchase of medical device in accordance with the provisions of these Measures;
(2) Entering the second category、The third type of medical device wholesale business and the third type of medical device retail business have not established and implemented the sales record system in accordance with these Measures.。
Chapter 6 Affiliation
Article 62 The meaning of the following words in these Measures is:
Medical Device Operation，refers to the behavior of providing medical device products in the form of purchase and sales，Including purchasing、Acceptance、Storage、Sales、Transportation、After -sales service, etc.。
Wholesale of medical equipment，refers to the business behavior of selling medical devices to a qualified business enterprise or a medical device for use。
Medical Device Retail，refers to the business behavior of medical device that sells medical devices directly to consumers。
Article 63 The relevant management regulations of Internet medical device operation shall be formulated separately by the State Food and Drug Administration。
Article 64 "Medical Device Business License" and the format of medical device business filing vouchers shall be formulated by the State Food and Drug Administration for uniformly formulated。
"Medical Devices Business License" and medical device business filing vouchers are printed by the municipal food and drug supervision and management department of the district。
The arrangement of the "Medical Device Business License" number is: XX Food and Drug Administration Operation Xu XXXXXXXX Number。Where:
The first place X represents the province where the license department is located、Autonomous Region、Abbreviation of municipalities directly under the Central Government;
The second X stands for the short name of the municipal administrative area where the place where is located;
Third to six digits x represents the year 4 digits permit;
Seventh to 10 X represents the 4 -digit license flow.
The arrangement of the second type of medical device business filing voucher is: XX food and drug monitoring operation preparation xxxxxxxx number。Where:
The first place X represents the place where the filing department is located、Autonomous Region、Abbreviation of municipalities directly under the Central Government;
The second X stands for the short name of the municipal administrative area where the place where is located;
The third to six digits X represent the year of the 4 -digit filing;
Seventh to 10 X represents the 4 -digit filing flow.
Article 65 "Medical Devices Business License" and the business scope of the medical device business filing certificate shall be according to the category of medical device management、Classification Coding and Name OK。Medical Device Management Category、Category codes and names are approved in accordance with the category category of medical device categories issued by the State Food and Drug Administration。
Article 66 The medical device business license electronic certificate produced by the food and drug supervision and management department is the same legal effect as the printed medical device operation license。
Article 67 This Measures will be implemented from October 1, 2014。The Administrative Measures for the "Management Measures for Medical Device Operation Enterprise License" released on August 9, 2004 (State Food and Drug Administration Order No. 15)。
