How can I sell medical devices online?
Last Friday, the State Food and Drug Administration officially issued the "Measures for the Supervision and Administration of Medical Device Network Sales" (Order No. 38 of the State Food and Drug Administration), which clarified the online sales of medical devices. It is also clear that the "Measures" will be formally implemented on March 1, 2018. How can I engage in online sales of medical devices? The "Measures" clarify the principle of "consistent online and offline". Enterprises engaged in the sales of medical device networks shall apply for the medical device production license, business license or legal entity for the production and operation of the medical device. The holder of the medical device marketing license (ie the medical device registrant or the filer) required by the Regulations on the Supervision and Administration of Medical Devices and the Measures. The holder sells its medical equipment through the network. The medical device manufacturing enterprise is entrusted by the holder to sell the medical equipment entrusted to be produced through the network. It does not need to apply for a business license or record. The sales conditions shall comply with the Regulations on the Supervision and Administration of Medical Devices and this The requirements of the approach. If the holder entrusts the sale of medical device network, it shall evaluate and confirm the legal qualifications, sales conditions, technical level and quality management capabilities of the trustee, guide and supervise the network sales process and quality control, and be responsible for the quality of medical devices sold online. . The operating model is to sell medical devices through self-built websites (including web client applications) or third-party platforms for medical device network transaction services. The third-party platform provider of medical device network transaction service refers to only the transaction services such as webpage space, virtual trading place, trading rules, transaction matching, electronic order, etc. in the medical device network transaction, for the transaction parties or parties to carry out trading activities, Companies directly involved in the sale of medical devices. What are the requirements for the website? The Measures also clearly stipulate that medical device network information services shall be implemented in accordance with the Measures for the Administration of Internet Drug Information Services. Therefore, enterprises engaged in the sale of medical device networks through self-built websites and third-party platform providers of medical device network transaction services shall obtain the Internet drug information service qualification certificate in accordance with the Measures for the Administration of Internet Drug Information Services. Enterprises engaged in the sales of medical device networks shall fill out the medical device network sales information form, and name the company, legal representative or principal responsible person, website name, network client application name, website domain name, website IP address, and telecommunication business operation license. Information such as the registration number of the certificate or non-operating Internet information service, the license for the production or operation of the medical device, or the number of the registration certificate shall be submitted to the municipal food and drug supervision and administration department of the local district for the record. If the relevant information changes, the record shall be changed in time. Enterprises that sell medical device networks through self-built websites should have office space suitable for their scale, as well as technical conditions such as data backup and failure recovery. Enterprises engaged in the sales of medical device networks shall display their medical device production and operation licenses or filing vouchers in a prominent position on their main pages. The product page should display the medical device registration certificate or filing certificate for the product. Relevant display information should be clear and easy to identify. Among them, the number of medical device production and operation licenses or filing vouchers, medical device registration certificates or filing vouchers shall also be displayed in text form. If the relevant information changes, the content of the display shall be updated in a timely manner. Name, model, specification, structure and composition of the medical device published by the enterprise engaged in medical device network sales, scope of application, medical device registration certificate number or record number, registrant or filer information, production license or record number Information such as product technical requirements number and contraindications shall be consistent with the relevant contents registered or filed. Enterprises engaged in the sales of medical device networks shall record the sales information of medical devices. The records shall be kept for 2 years after the expiration date of the medical devices; if there is no expiration date, the storage time shall not be less than 5 years; the sales information of implanted medical devices shall be permanently stored. Relevant records should be true, complete and traceable. What are the requirements for selling products? The scope of medical device network business shall not exceed the scope of its production and operation license or filing. Medical device wholesale enterprises engaged in medical device network sales should be sold to qualified medical device operators or users. Medical device retail enterprises engaged in medical device network sales should be sold to consumers. Medical devices sold to consumers should be self-contained by the consumers themselves. The instructions should conform to the medical device specifications and label management regulations, and specify special instructions for safe use. Medical devices that should be used by medical institutions cannot be sold to individuals. What do third-party platforms for medical device network transaction services need to do? The first is to fulfill the record-keeping obligations. Enterprises engaged in the sales of medical device networks shall file with the municipal food and drug supervision and administration department of the locality where the localities are located, and if the relevant information changes, the record information shall be changed in a timely manner. The third-party platform provider of the medical device network transaction service shall file with the local provincial food and drug supervision and administration department for the record. If the relevant filing information changes, it shall be changed in time for filing. Complete the third-party platform filing form for medical device network transaction services and submit the following materials: (1) The original and photocopy of the business license; (2) The original or photocopy of the legal representative or principal responsible person and the identity certificate of the medical device quality and safety manager; (3) Description of the organization and department setting; (4) The original and copy of the geographical location map of the office, the house property certificate or the lease agreement (with the house property certificate); (5) The original, copy or non-operating Internet information service record of the telecommunications business license; (6) The original and photocopy of the "Internet Drug Information Service Qualification Certificate"; (7) A list of documents such as the quality management system for medical device network transaction services; (8) Basic information and function description of the website or network client application; (9) Other relevant certification materials. The second is to establish a system for the quality management of medical devices. Third-party platform providers of medical device network transactions shall establish and implement medical device production and operation enterprises on the platform to verify registration, quality and safety monitoring, transaction security, online sales violations and reports, serious illegal service platform services, and safety complaints reports. Management systems such as handling, consumer rights protection, and quality and safety information announcements. The third is to review the registration obligations. The third-party platform provider of medical device network transaction shall verify and register the medical device production and operation license or record certificate, medical device registration certificate or record certificate, business license and other materials provided by the medical device production and operation enterprise applying for the platform. The files will be updated in a timely manner, and an entry agreement will be signed with the medical device production and operation enterprises on the platform to clarify the obligations of both parties and the measures for breach of contract. The fourth is the qualifications, places, technical conditions and relevant requirements of management personnel. Enterprises engaged in medical device network sales and third-party platform providers of medical device network transactions shall obtain the "Internet Drug Information Service Qualification Certificate" according to law, have the office space suitable for their scale, and the technical conditions such as data backup and fault recovery, and set up special Medical device network quality and safety management organization or medical device quality and safety management personnel. The fifth is the platform management obligation. The third-party platform provider of medical device network transactions shall monitor the sales behavior and information of medical devices on the platform, and find that the medical device production and operation enterprises that have entered the third-party platform of the online transaction service have illegal activities and should immediately stop the network transaction service. And keep relevant records and report to the local provincial food and drug supervision and administration department. If a medical device production and operation enterprise that has entered the third-party platform of the online transaction service is ordered by the food and drug supervision and administration department to suspend production or business suspension or revoke the license, it shall immediately stop providing online transaction services. Sixth is the obligation to record. Enterprises engaged in medical device network sales and third-party platform providers of medical device network transactions shall record medical device transaction information, records shall be kept for 2 years after the validity period of medical devices; if there is no validity period, the storage time shall not be less than 5 years; Medical device transaction information should be kept permanently. Technical measures should be taken to ensure that the medical device network sales data and data are authentic, complete and safe. What are the requirements for delivery? Enterprises engaged in the sale of medical device networks shall store and transport medical devices in accordance with the conditions indicated on the medical device labels and instructions. If other units are entrusted to store and transport medical equipment, the quality assurance ability of the medical equipment stored and transported by the entrusted party shall be assessed and evaluated, the quality responsibility during storage and transportation shall be clarified, and the quality and safety during storage and transportation shall be ensured. Duty of food and drug supervision at all levels The State Food and Drug Administration is responsible for guiding the supervision and management of the national medical device network sales and medical device network transaction services third-party platform, and organizing the national medical device network sales monitoring work. The provincial food and drug supervision and administration department is responsible for the supervision and management of the third-party platform of medical device network transaction services. The local food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of medical device network sales within its administrative region. What if there is a risk or a problem occurs? The food and drug supervision and administration department found in the inspection that the enterprise engaged in the sales of medical device network or the third-party platform of medical device network transaction service did not establish and implement the relevant quality management system as required, and if there is a hidden danger of medical device quality and safety, it may be ordered to suspend the network. Sell ​​or suspend related online trading services. If it is found that the medical device network sales enterprise or the medical device network transaction service third-party platform has the quality and safety of medical devices, which may lead to the quality and safety risks of medical devices, etc., the legal representative or the principal person in charge may be interviewed according to the duties. . In addition, medical devices that cause harm to the human body or have evidence to prove that it may endanger human health, the Regulations on the Supervision and Administration of Medical Devices have clearly stipulated that the food and drug supervision and administration department may adopt emergency control measures to suspend production, import, operation and use. The food and drug supervision and administration department may, in the case of a network sales enterprise or a medical device network transaction service third party platform provider who refuses to perform the suspension of network sales, suspends the provision of related network transaction services, or refuses to comply with the requirements after the interview, the food and drug supervision department may The person or principal responsible person is included in the list of untrustworthy enterprises and untrustworthy persons, and is disclosed to the public. About the record number The arrangement of the document number of the third-party platform for medical device network transaction service is: (X) Network equipment platform word [XXXX] No. XXXXX. among them: The first X represents the abbreviation of the province, autonomous region, or municipality directly under the Central Government where the filing department is located; The second to fifth digits represent the 4-digit filing year; The sixth to tenth X represents the 5-digit record number. State Food and Drug Administration No. 38 The Measures for the Supervision and Administration of Medical Device Network Sales was reviewed and approved by the State Food and Drug Administration at the Bureau of the State Council on November 7, 2017. It is hereby promulgated and will be implemented as of March 1, 2018. Director: Bi Jingquan December 20, 2017 Medical Device Network Sales Supervision and Management Measures Chapter I General Provisions The first one is to strengthen the supervision and management of medical device network sales and medical device network transaction services, and to protect public safety. According to the "Network Security Law of the People's Republic of China", "Regulations on Medical Device Supervision and Administration", "Administrative Measures on Internet Information Services" and other laws and regulations. Formulate these measures. Article 2 These Measures shall be observed in the sale of medical device networks, the provision of medical device network transaction services and their supervision and management within the territory of the People's Republic of China. Article 3 The State Food and Drug Administration shall be responsible for guiding the supervision and management of the national medical device network sales and medical device network transaction services, and organizing the national medical device network sales and network transaction service monitoring. The provincial food and drug supervision and administration department is responsible for the supervision and management of medical device network transaction services. The local food and drug supervision and administration department at or above the county level shall be responsible for the supervision and management of medical device network sales within its administrative region. Article 4 The enterprises engaged in the network sales of medical devices and the third-party platform providers of medical device network transaction services shall abide by the regulations, rules and regulations of medical devices, establish and improve the management system, operate in good faith according to law, and ensure the quality and safety of medical devices. Enterprises engaged in the sales of medical device networks refer to the holders of medical device marketing licenses (ie medical device registrants or filers, hereinafter referred to as holders) and medical device production and operation enterprises that sell medical devices through the Internet. The third-party platform provider of medical device network transaction service refers to only the transaction services such as webpage space, virtual trading place, trading rules, transaction matching, electronic order, etc. in the medical device network transaction, for the transaction parties or parties to carry out trading activities, Companies directly involved in the sale of medical devices. Article 5 The third-party platform providers engaged in the sales of medical device networks and medical device network transaction services shall take technical measures to ensure the authenticity, completeness and traceability of medical device network sales data and materials. Article 6 The enterprises engaged in the sales of medical device networks and the third-party platform providers of medical device network transaction services shall actively cooperate with the food and drug supervision and administration department to carry out supervision and management such as network monitoring, sampling inspection and on-site inspection, in accordance with the requirements of the food and drug supervision and administration department. Store data, provide information query, data extraction and other related support. Chapter II Medical Device Network Sales Article 7 Enterprises engaged in the sales of medical device networks shall be medical device production and operation enterprises that have obtained medical device production licenses, business licenses or filed for legal records. Except for laws and regulations that do not require permission or filing. The holder sells its medical equipment through the network. The medical device manufacturing enterprise is entrusted by the holder to sell the medical equipment entrusted to be produced through the network. It does not need to apply for a business license or record. The sales conditions shall comply with the Regulations on the Supervision and Administration of Medical Devices and this The requirements of the approach. If the holder entrusts the sale of medical device network, it shall evaluate and confirm the legal qualifications, sales conditions, technical level and quality management capabilities of the trustee, guide and supervise the network sales process and quality control, and be responsible for the quality of medical devices sold online. . Article 8 Enterprises engaged in the sales of medical device networks shall fill out the medical device network sales information form, the name of the enterprise, the legal representative or principal responsible person, the name of the website, the name of the network client application, the domain name of the website, the IP address of the website, and the telecommunications Business license or non-operating Internet information service record number, medical device production and operation license or record number and other information shall be submitted to the municipal food and drug supervision and administration department of the local district for the record. If the relevant information changes, the record shall be changed in time. Article 9 Enterprises engaged in the sales of medical device networks shall conduct medical device network sales activities through self-built websites or third-party platforms for medical device network transaction services. Enterprises that conduct medical device network sales through self-built websites shall obtain the "Internet Drug Information Service Qualification Certificate" according to law, and have the office facilities suitable for their scale, as well as technical conditions such as data backup and fault recovery. Article 10 An enterprise engaged in the sales of medical device networks shall display its medical device production and operation license or record certificate in a prominent position on its main page. The product page shall display the medical device registration certificate or record certificate of the product. Relevant display information should be clear and easy to identify. Among them, the number of medical device production and operation licenses or filing vouchers, medical device registration certificates or filing vouchers shall also be displayed in text form. If the relevant information changes, the content of the display shall be updated in a timely manner. Article 11 The name, model, specification, structure and composition of the medical device published by the enterprise engaged in the sale of medical device network, the scope of application, the registration number of the medical device or the number of the registration certificate, the information of the registrant or the filer, and the production license Or the information such as the record number, product technical requirement number, contraindications, etc., should be consistent with the relevant content registered or filed. Article 12 Enterprises engaged in the sales of medical device networks shall record the sales information of medical devices, and the records shall be kept for 2 years after the expiration date of the medical devices; if there is no expiration date, the storage time shall not be less than 5 years; the sales information of implanted medical devices shall be Save forever. Relevant records should be true, complete and traceable. Article 13 The business scope of an enterprise engaged in the sale of medical device networks shall not exceed the scope of its production and operation license or filing. Medical device wholesale enterprises engaged in medical device network sales should be sold to qualified medical device operators or users. Medical device retail enterprises engaged in medical device network sales should be sold to consumers. Medical devices sold to consumers should be self-contained by the consumers themselves. The instructions should conform to the medical device specifications and label management regulations, and specify special instructions for safe use. Article 14 Enterprises engaged in the sale of medical device networks shall store and transport medical devices in accordance with the conditions indicated in the medical device labels and instructions. If other units are entrusted to store and transport medical equipment, the quality assurance ability of the medical equipment stored and transported by the entrusted party shall be assessed and evaluated, the quality and safety responsibility during storage and transportation shall be clarified, and the quality and safety during storage and transportation shall be ensured. Chapter III Medical Device Network Trading Service Article 15 The third-party platform provider of medical device network transaction service shall obtain the "Internet Drug Information Service Qualification Certificate" according to law, have the office space suitable for its scale, and the technical conditions such as data backup and fault recovery, and set up a special medical device network. The quality and safety management organization is equipped with medical device quality and safety management personnel. Article 16 The third-party platform provider of medical device network transaction service shall file with the local provincial food and drug supervision and administration department, fill out the third-party platform record form of medical device network transaction service, and submit the following materials: (1) The original and photocopy of the business license; (2) The original or photocopy of the legal representative or principal responsible person and the identity certificate of the medical device quality and safety manager; (3) Description of the organization and department setting; (4) The original and copy of the geographical location map of the office, the house property certificate or the lease agreement (with the house property certificate); (5) The original, copy or non-operating Internet information service record of the telecommunications business license; (6) The original and photocopy of the "Internet Drug Information Service Qualification Certificate"; (7) A list of documents such as the quality management system for medical device network transaction services; (8) Basic information and function description of the website or network client application; (9) Other relevant certification materials. Article 17 The provincial food and drug supervision and administration department shall check the integrity of the materials submitted by the enterprise on the spot, file the records in accordance with the regulations, and issue the documents for the third-party platform of the medical device network transaction service; the submitted materials are incomplete or do not meet the statutory requirements. In the case, the matter requiring supplementary materials should be notified at one time. The provincial food and drug supervision and administration department shall disclose relevant filing information to the public within 7 working days after the filing. The filing information includes the company name, legal representative or principal responsible person, website name, network client application name, website domain name, website IP address, telecommunication business operation license or non-operating Internet information service registration number, medical device network transaction. Service third party platform record certificate number, etc. The provincial food and drug supervision and administration department shall conduct on-site inspection of the third-party platform of the medical device network transaction service within 3 months after the third-party platform provider of the medical device network transaction service is filed. Article 18 Name, legal representative or principal responsible person of the third-party platform of medical device network transaction service, website name, network client application name, website domain name, website IP address, telecommunication business operation license or non-operating If the filing information of the Internet information service record number changes, it shall be changed in time for filing. Article 19 The third-party platform provider of the medical device network transaction service shall mark the number of the document for the third-party platform for the medical device network transaction service in a prominent position on the main page of the website. Article 20: Third-party platform providers of medical device network transaction services shall establish enterprise verification registration, quality and safety monitoring, transaction security protection, network sales illegal behavior suppression and reporting, serious illegal behavior platform service stop, and safety complaint report. Management systems such as handling, consumer rights protection, and quality and safety information announcements. Article 21 The third-party platform provider of medical device network transaction service shall verify the medical device production and operation license or record certificate, medical device registration certificate or record certificate, business license and other materials provided by the enterprise applying for the platform. Establish archives and update them in a timely manner to ensure that the licenses or filing information of the production and business premises as stated in the enterprise licenses or filing documents of the platform are true. The provider of the third-party platform of the medical device network transaction service shall sign a settlement agreement with the enterprise that has entered the platform, and clarify the obligations of both parties and the measures for breach of contract in the agreement. Article 22 The third-party platform provider of medical device network transaction service shall record the medical device transaction information carried out on its platform. The record shall be kept for 2 years after the validity period of the medical device; if there is no validity period, the storage time shall not be less than 5 years. Implanted medical device transaction information should be kept permanently. Relevant records should be true, complete and traceable. Article 23: Third-party platform providers of medical device network transaction services shall monitor the sales behavior and information of medical devices on the platform, and find that enterprises that have entered the third-party platform of online transaction services have over-range operations, publish false information, and exaggerate publicity. If violations of laws and regulations, inability to obtain contact, or other serious safety hazards, they shall immediately stop the online transaction service, and keep relevant records to report to the local provincial food and drug supervision and administration department. If the enterprise that has entered the third-party platform of the online transaction service is ordered by the food and drug supervision and administration department to suspend production or business suspension, revoke the license, etc., or the products of the platform transaction are suspended or stopped by the food and drug supervision and administration department, the relevant network shall be immediately stopped. Trading services. Article 24: Third-party platform providers of medical device network transaction services shall promptly release relevant information such as product quality and safety hazards in a prominent position on the website. Chapter IV Supervision and Inspection Article 25 The food and drug supervision and administration department shall, in accordance with the provisions of laws, regulations and rules, exercise supervision and inspection and sampling inspection on the third-party platforms for enterprises engaged in medical device network sales and medical device network transaction services. Article 26 The investigation and punishment of illegal activities of enterprises engaged in the sale of medical device networks shall be under the jurisdiction of the local food and drug supervision and administration department at or above the county level. If it is determined that the address of the illegal sales enterprise is not authorized or filed for medical device network sales, it shall be under the jurisdiction of the local food and drug supervision and administration department at or above the county level where the illegal sales enterprise is located; if the location of the illegal sales enterprise cannot be determined, the place where the illegal act occurs or illegal The local food and drug supervision and administration department at or above the county level is subject to the jurisdiction of the behavior. If it is sold through a third-party platform of the medical device network transaction service, it shall be under the jurisdiction of the provincial food and drug supervision and administration department where the third party platform provider of the medical device network transaction service is located; after the investigation, the jurisdiction may be determined, and the food and drug with jurisdiction shall be transferred in time. Supervise management. The investigation and punishment of the illegal activities of the third-party platform providers of medical device network transaction services shall be under the jurisdiction of the provincial food and drug supervision and administration department. If a Medical Product sold on the Internet has a major quality accident or causes other serious harms, it may be under the jurisdiction of the provincial food and drug supervision and administration department where the illegal enterprise is located, the place where the illegal act occurred or the result of the illegal act; the provincial food and drug with particularly serious consequences The supervisory and administrative department may report to the State Food and Drug Administration for coordination or organize direct investigation. For the websites where the medical device network sales violations occur, the provincial food and drug supervision and administration department shall notify the communication authorities at the same level. Article 27 The State Food and Drug Administration shall organize the establishment of a national medical device network transaction monitoring platform, conduct national medical device network sales and network transaction monitoring and disposal, and regularly report to the provincial food and drug supervision and administration department. The suspected illegal and illegal information discovered by the monitoring shall be promptly transferred to the relevant provincial food and drug supervision and administration department. The provincial food and drug supervision and administration department shall organize and handle it in a timely manner. Article 28 The medical device network sales monitoring platform established by the provincial food and drug supervision and administration department shall implement data docking with the national medical device network transaction monitoring platform. Article 29 The food and drug supervision and administration department shall, when conducting daily supervision and management of medical device network sales, or investigate and deal with the sale of medical device networks suspected of violating laws and regulations, have the right to take the following measures: (1) Entering on-site inspections of enterprise medical device business premises, office space and server location; (2) Sampling inspection of medical devices sold online; (3) Inquiring about relevant personnel and investigating the relevant situation of the company engaged in the sales of medical device networks; (4) consulting and copying the transaction data, contracts, bills, books and other relevant materials of the enterprise; (5) Retrieving technical monitoring and recording data of network sales; (6) Seizing and seizing data storage media, etc. according to law; (7) Other measures that can be taken by laws and regulations. Article 30 The sampling inspection of online sales of medical devices shall be carried out in accordance with the relevant management regulations for quality inspection and inspection of medical devices. If the inspection result does not meet the quality and safety standards of medical devices, the food and drug supervision and administration department shall, after receiving the inspection report, conduct supervision and inspection of relevant production and operation enterprises in a timely manner, take control measures, issue quality announcements in a timely manner, and investigate and deal with illegal acts according to law. Article 31 The food and drug supervision and administration department's technical monitoring records and information traceability data for medical device network sales may be used as the basis for determining the illegal facts of medical device network sales. Article 32 If the actual situation of an enterprise engaged in the sale of medical device network is inconsistent with the filing information and cannot be contacted, the municipal food and drug supervision and administration department of the locality shall, after being publicized by the municipal food and drug supervision and administration department, cancel the Medical Device Operation Permit or In the second type of medical device business record information, it will be marked and announced to the public. The relevant website shall be notified by the provincial food and drug supervision and administration department at the same level of communication. If the actual situation of the provider of the third-party platform of the medical device network transaction service is inconsistent with the record information and cannot be contacted, it shall be marked in the record information and announced to the public after being publicized by the provincial food and drug supervision and administration department where the original record is located; Where false information is provided, the provincial food and drug supervision and administration department shall publicize the filing unit to the public. The website of the provincial food and drug supervision and administration department shall notify the communication department at the same level. Article 33 The food and drug supervision and administration department found in the inspection that the enterprise engaged in the sales of medical device networks or the third-party platform of the medical device network transaction service did not establish and implement the relevant quality management system as required, and there were hidden dangers in the quality and safety of medical devices. The food and drug supervision department may order it to suspend online sales or suspend the provision of related online transaction services. To resume online sales or to resume the provision of related online transaction services, enterprises engaged in medical device network sales or third-party platform providers of medical device network transaction services shall submit an application to the food and drug supervision and administration department that has made the decision on the basis, and the food and drug supervision and administration department. The inspection can be resumed by the rear. Article 34. In the case of a company engaged in the sale of medical device networks and a third-party platform provider of medical device network transaction services, the food and drug supervision and administration department may, according to its duties, conduct an appointment with its legal representative or principal responsible person. talk: (1) The quality and safety of medical devices may cause medical device quality and safety risks; (2) Failure to properly handle the quality of medical devices complained of and reported in a timely manner, there may be hidden dangers in the quality and safety of medical devices; (3) failing to take effective measures to promptly investigate and eliminate the hidden dangers of quality and safety of medical devices, and fail to fulfill the responsibility for quality and safety of medical devices; (4) Other situations in which interviews are required. The interview will not affect the food and drug supervision and administration department to carry out administrative treatment according to law, and the interview situation and follow-up treatment can be disclosed to the public. If the interviewed enterprise fails to implement the rectification according to the requirements without proper reasons, the provincial food and drug supervision and administration department and the municipal food and drug supervision and administration department of the locality shall increase the frequency of supervision and inspection according to their duties. Article 35 In any of the following circumstances, the food and drug supervision and administration department may include the enterprises engaged in the sales of medical device networks, the third-party platform providers of medical device network transaction services, and their legal representatives or principals in the untrustworthy enterprise. And a list of people who are untrustworthy and open to the public: (1) refusing to implement the decision to suspend network sales or suspend the provision of related online transaction services; (2) After the company is interviewed, it refuses to rectify it as required. Article 36 The local food and drug supervision and administration department at or above the county level shall regularly analyze the supervision and management of the medical device network sales in the administrative region, report the food and drug supervision and administration department at the higher level, and disclose it to the public according to law. The provincial food and drug supervision and administration department shall summarize and analyze the supervision and management of the third-party platform of medical device network sales and online transaction services, report to the State Food and Drug Administration, and disclose it to the public according to law. Chapter V Legal Liability Article 37. Enterprises engaged in the sale of medical device networks and third-party platform providers of medical device network transaction services are engaged in sales or transaction services in violation of the relevant provisions of laws and regulations. Where laws and regulations already stipulate, the provisions shall be followed. If it constitutes a crime, it shall be transferred to the public security organ for handling. Article 38 Whoever violates the provisions of these Measures and fails to obtain a medical device operation license to engage in the sale of the third category medical device in the network shall be punished in accordance with the provisions of Article 63 of the Regulations on the Supervision and Administration of Medical Devices; Where the equipment operation record voucher is engaged in the sale of the second type of medical equipment in the network, it shall be punished in accordance with the provisions of Article 65 of the Regulations on the Supervision and Administration of Medical Devices. Article 39 If an enterprise engaged in the sale of medical device network fails to file a record in accordance with the provisions of these Measures, the local food and drug supervision and administration department at or above the county level shall order it to make corrections within a time limit and give a warning; if it refuses to make corrections, it shall announce to the public that it shall be 10,000 yuan. The following fine. Article 40 In any of the following circumstances, the local food and drug supervision and administration department at or above the county level shall order it to make corrections and give a warning; if it refuses to make corrections, it shall be fined not less than 5,000 yuan but not more than 10,000 yuan: (1) The enterprise engaged in the sales of medical device network fails to display the medical device production and operation license or the record certificate, the medical device registration certificate or the record certificate in accordance with the requirements of these Measures; (2) The third-party platform provider of the medical device network transaction service fails to display the third-party platform record certificate number of the medical device network transaction service in accordance with the requirements of these Measures. Article 41 If any of the following circumstances occurs, the local food and drug supervision and administration department at or above the county level shall order it to make corrections and give a warning; if it refuses to make corrections, it shall be fined not less than 5,000 yuan but not more than 20,000 yuan: (1) The information on the filing of the enterprise engaged in the sales of medical device networks has changed and has not been changed as required; (2) Enterprises engaged in the sales of medical device networks fail to establish and implement quality management systems as required; (3) The changes in the filing of the third-party platform provider of the medical device network transaction service have not been changed as required; (4) The third-party platform provider of medical device network transaction service fails to set up a quality and safety management institution or a quality and safety management personnel that is suitable for its scale according to the requirements; (5) The third-party platform provider of medical device network transaction service fails to establish and implement the quality management system as required. Article 42 If a third-party platform provider of medical device network transaction services fails to file a record in accordance with the provisions of these Measures, the provincial food and drug supervision and administration department shall order it to make corrections within a time limit; if it refuses to make corrections, it shall make a public announcement and impose a fine of not more than 30,000 yuan. . 第四å三æ¡æœ‰ä¸‹åˆ—情形之一的，由县级以上地方食å“è¯å“监ç£ç®¡ç†éƒ¨é—¨è´£ä»¤æ”¹æ£ï¼Œç»™äºˆè¦å‘Šï¼›æ‹’ä¸æ”¹æ£çš„，处1万元以上3万元以下罚款： （一）从事医疗器械网络销售的ä¼ä¸šã€åŒ»ç–—器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°æ¡ä»¶å‘生å˜åŒ–，ä¸å†æ»¡è¶³è§„定è¦æ±‚çš„ï¼› （二）从事医疗器械网络销售的ä¼ä¸šã€åŒ»ç–—器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°æ供者ä¸é…åˆé£Ÿå“è¯å“监ç£ç®¡ç†éƒ¨é—¨çš„监ç£æ£€æŸ¥ï¼Œæˆ–者拒ç»ã€éšçž’ã€ä¸å¦‚实æ供相关æ料和数æ®çš„。 第四åå››æ¡æœ‰ä¸‹åˆ—情形之一的，由县级以上地方食å“è¯å“监ç£ç®¡ç†éƒ¨é—¨è´£ä»¤æ”¹æ£ï¼Œå¤„1万元以上3万元以下罚款： （一）从事医疗器械网络销售的ä¼ä¸šè¶…出ç»è¥èŒƒå›´é”€å”®çš„ï¼› （二）医疗器械批å‘ä¼ä¸šé”€å”®ç»™ä¸å…·æœ‰èµ„质的ç»è¥ä¼ä¸šã€ä½¿ç”¨å•ä½çš„。 医疗器械零售ä¼ä¸šå°†éžæ¶ˆè´¹è€…自行使用的医疗器械销售给消费者个人的，ä¾ç…§å‰æ¬¾ç¬¬ä¸€é¡¹è§„定予以处罚。 第四å五æ¡ä»Žäº‹åŒ»ç–—器械网络销售的ä¼ä¸šæœªæŒ‰ç…§åŒ»ç–—å™¨æ¢°è¯´æ˜Žä¹¦å’Œæ ‡ç¾æ ‡ç¤ºè¦æ±‚è¿è¾“ã€è´®å˜åŒ»ç–—器械的，ä¾ç…§ã€ŠåŒ»ç–—器械监ç£ç®¡ç†æ¡ä¾‹ã€‹ç¬¬å…å七æ¡çš„规定予以处罚。 第四åå…æ¡è´Ÿè´£ç›‘管医疗器械网络销售的食å“è¯å“监ç£ç®¡ç†éƒ¨é—¨å·¥ä½œäººå‘˜ä¸å±¥è¡ŒèŒè´£æˆ–者滥用èŒæƒã€çŽ©å¿½èŒå®ˆã€å¾‡ç§èˆžå¼Šçš„，ä¾æ³•è¿½ç©¶è¡Œæ”¿è´£ä»»ï¼›æž„æˆçŠ¯ç½ªçš„，移é€å¸æ³•æœºå…³è¿½ç©¶åˆ‘事责任。 第四å七æ¡åŒ»ç–—器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°æ供者æ供的医疗器械产å“或者æœåŠ¡é€ æˆä»–人人身ã€è´¢äº§æŸå¤±çš„ï¼Œæ ¹æ®ç›¸å…³æ³•å¾‹æ³•è§„的规定承担民事责任。 Chapter VI Supplementary Provisions 第四åå…«æ¡åŒ»ç–—器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°å¤‡æ¡ˆå‡è¯çš„æ ¼å¼ç”±å›½å®¶é£Ÿå“è¯å“监ç£ç®¡ç†æ€»å±€ç»Ÿä¸€åˆ¶å®šã€‚ 医疗器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°å¤‡æ¡ˆå‡è¯ç”±çœçº§é£Ÿå“è¯å“监ç£ç®¡ç†éƒ¨é—¨å°åˆ¶ã€‚ 医疗器械网络交易æœåŠ¡ç¬¬ä¸‰æ–¹å¹³å°å¤‡æ¡ˆå‡è¯ç¼–å·çš„编排方å¼ä¸ºï¼šï¼ˆX）网械平å°å¤‡å—〔XXXX〕第XXXXXå·ã€‚ among them: 第一ä½X代表备案部门所在地çœã€è‡ªæ²»åŒºã€ç›´è¾–市的简称； 第二到五ä½X代表4ä½æ•°å¤‡æ¡ˆå¹´ä»½ï¼› 第å…到åä½X代表5ä½æ•°å¤‡æ¡ˆæµæ°´å·ã€‚ 第四åä¹æ¡åŒ»ç–—器械网络信æ¯æœåŠ¡æŒ‰ç…§ã€Šäº’è”网è¯å“ä¿¡æ¯æœåŠ¡ç®¡ç†åŠžæ³•ã€‹æ‰§è¡Œã€‚ 第五åæ¡æœ¬åŠžæ³•è‡ª2018å¹´3月1日起施行。 Tetanus Shot,Tetanus Vaccine,Hepatitis B Injection,Hep B Vaccine FOSHAN PHARMA CO., LTD. , https://www.fspharmamedicine.com