Chapter 1 General Principles

Article 1 In order to strengthen the supervision and management of medical device online sales and medical device network transaction services，Guarantee public weapon safety，According to the "People's Republic of China Network Security Law", "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Internet Information Services"，Formation of this method。

II: Sales of Medical Device Networks in the People's Republic of China、Provide medical device network transaction services and its supervision and management，It should abide by these Measures。

Article 3 The State Administration of Food and Drug Administration is responsible for guiding the online sales of medical device in the country、Supervision and management of medical device network transaction services，Organize the monitoring of online sales and network transaction services for medical devices in the country。
Provincial food and drug supervision and management department is responsible for supervision and management of medical device network transaction services。
The local food and drug supervision and management department at or above the county level is responsible for the supervision and management of online sales of medical device networks in the administrative region。

4 Enterprises engaged in online sales of medical device、Medical Device Network Transaction Services Third -Party Platform Provider shall comply with medical device regulations、Regulations and specifications，Establish a sound management system，Operation according to law，Make sure the quality and safety of medical equipment。
Enterprises engaged in medical device online，refers to the holder of medical device listing of medical device sales through the Internet (that is, medical device registrar or recorder，The following is referred to as holders) and medical device production and operation enterprises。
Medical Devices Network Transaction Services Third -Party Platform Provider，refers to only webpage spaces in medical device network transactions、Virtual trading venue、Trading rules、Transaction matching、Electronic orders and other transaction services，For transactions for both parties or parties to carry out transaction activities，Enterprises that do not directly participate in medical device sales。

Fifth Enterprise、Medical Device Network Transaction Services Third -Party Platform Provider shall take technical measures，Guarantee the authenticity of the online sales data and information of medical device、Full、traceable。

6 Enterprises engaged in online sales of medical device、Medical Device Network Transaction Services Third -Party Platform Provider shall actively cooperate with the food and drug supervision and management department to carry out network monitoring、Sample test、On -site inspection and other supervision and management，Storage data in accordance with the requirements of the food and drug supervision and management department，Provide information query、Data extraction and other related support。

Chapter 2 Medical Device Network Sales

7 Enterprises engaged in online sales of medical device should obtain medical device production licenses in accordance with the law、Management and operation enterprise of medical device for business license or filing。Laws and regulations stipulate that no license or filing is required。
The holder sells its medical equipment through the Internet，Medical Device Manufacturers are entrusted to sell medical devices for sale through the Internet，No need to apply for business license or filing，Its sales conditions shall meet the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and the requirements of these Measures。
The holder entrusts the sales of medical device network，It should be evaluated and confirmed that the legal qualifications of the trustee、Sales conditions、Technical level and quality management ability，Guide and supervise the online sales process and quality control，Responsible for the quality of medical equipment sold online。

Enterprises engaged in online sales of medical device，Should fill in the medical device network sales information form，The name of the enterprise、Legal representative or main person in charge、Website name、Network client application name、Website domain name、Website IP address、Telecom business business license or non -operating Internet information service filing number、Medical Devices Production and Management License Certificate or Filing Voucher Number, etc.。Related information changes，Should change the filing in time。

No. 9 Enterprises engaged in online sales of medical device，It shall carry out medical device network sales activities through self -built websites or medical device network transactions for third -party platforms。
Enterprises selling medical device networks through self -built websites，The "Internet Drug Information Service Qualification Certificate" should be obtained in accordance with the law，and have an office venue that is compatible with its scale and data backup、Technical conditions such as fault recovery。

Article 10 Enterprises engaged in online sales of medical device，Should display the production and operation license or filing voucher for its medical device production and operation on its homepage，The product page shall display the medical device registration certificate or filing voucher of the product。Related display information should be clear，Easy recognition。Where，Medical Device Production and Management License or Filter Certificate、The number of medical device registration certificates or filing vouchers should also be displayed in text form。Related information changes，The content of the display should be updated in time。

Article 11 The name of a medical device named by enterprises engaged in the online sales of medical equipment、Model、Specification、Structure and composition、Applicable range、Registration certificate number or filing voucher number、Register or the stake betting apprecorder information、Production license or filing voucher number、Product technical requirements number、contraindications and other information，It should be consistent with the relevant content of the registered or filing。

Article 12 Enterprises engaged in online sales of medical device shall record medical device sales information，Records should be stored to 2 years after the effective period of medical equipment; if there is no validity period，The preservation time must not be less than 5 years; the sales information of implanted medical devices should be permanently stored。Related records should be true、Full、traceable。

Article 13 Enterprises engaged in online sales of medical device，The scope of business shall not exceed the scope of its production and operation permit or filing。
Medical Device Wholesale Enterprises engaged in medical device network sales，It should be sold to qualified medical device business enterprises or use units。
Medical device retail enterprises engaged in medical equipment network sales，It should be sold to consumers。Medical equipment sold to consumers personal，It should be used by consumers，Its manual shall comply with the relevant regulations of the medical device instructions and label management，Special instructions for safe use。

Article 14 Enterprises engaged in online sales of medical device，It should be stored and transported in accordance with the conditions indicated by the medical device label and instructions。Entrusted other units to store and transport medical equipment，The quality assurance capacity of the commissioned party stored and transported medical equipment should be evaluated and evaluated，Clarify the quality and safety responsibility in the process of storage and transportation，Make sure the quality and safety in the storage and transportation process。

Chapter 3 Medical Device Network Trading Service

Article 15 The provider of the third -party platform provider of medical device network transaction services shall obtain the "Internet Drug Information Service Qualification Certificate"，With the office venue that is compatible with its scale and data backup、Technical conditions such as fault recovery，Set special medical device network quality and safety management institution or equipped with medical equipment quality and safety managers。

Article 16 The provider of the third -party platform of the medical device network transaction service shall be filed with the provincial food and drug supervision and management department of the local area，Fill in the third -party platform filing form of the medical device network transaction service，and submit the following materials:
(1) Original and photocopy of the business license;
(2) Legal representative or main person in charge、The original identity of the quality and safety manager of medical equipment、Copy;
(3) Instructions for the organization and department settings;
(4) Geographical location of office space、Housing Property Certificate Documents or Rental Agreement (Certificate of Housing Property Rights Certificate) Original、Copy;
(5) Original of telecommunications business business license、Copy or non -operating Internet information service filing instructions;
(6) Original "Internet Drug Information Service Qualification Certificate"、Copy;
(7) The quality management system of medical device network transaction service quality management system and other file directory;
(8) Introduction and functional description of the basic situation of websites or network client applications;
(9) Other related certification materials.

Article 17 Provincial food and drug supervision and management departments shall check the integrity of the materials submitted by the enterprise on the spot，Packing in line with the requirements，Send to the medical device network transaction service third -party platform filing certificate; if the information is not complete or does not meet the statutory situation，It should be notified one -time matters that need to be supplemented。
Provincial food and drug supervision and management department shall disclose relevant filing information to the society within 7 working days after the filing。The filing information includes an enterprise name、Legal representative or main person in charge、Website name、Network client application name、Website domain name、Website IP address、Telecom business business license or non -operating Internet information service filing number、Medical Device Network Transaction Services Third -Party Platform File Valley Certificate Number, etc.。
Provincial food and drug supervision and management departments shall be within 3 months after the third -party platform provider of the medical device network transaction service，On -site inspections of the third -party platform of medical device network transaction services。

Article 18 The name of the provider of the third -party platform of the medical device network transaction service、Legal representative or main person in charge、Website name、Network client application name、Website domain name、Website IP address、Telecom business business license or non -operating Internet information service filing number and other filing information changes，Should change the filing in time。

Article 19 Provisters of the third -party platform of medical device network transaction services，It should be marked on the homepage of its website to mark the number of medical device network transaction services for third -party platform filing vouchers。

Article 20 The third -party platform provider of the third -party platform of the medical device network transaction service shall establish an enterprise verification registration including the settlement platform、Quality and Safety Monitoring、Trading security protection、Online sales illegal acts to stop and report、Serious illegal behavior platform service stops、Security complaint report processing、Consumer Rights Protection、Quality and Security Information Announcement and other management systems。

21 The third -party platform provider of the third -party platform of the medical device network transaction service shall be the medical device production and operation license or filing voucher provided by the enterprise that applies to the platform、Medical Devices Registration Certificate or Filter Certificate、Materials such as business license and other materials for verification，Create a file and update it in time，Make or license or filing information of the production and operation place that guarantees the corporate license of the entry platform or the filing certificate。
Medical Devices Network Transaction Services Third -Party Platform Provider shall sign an entry agreement with the enterprise on the platform，and in the agreement clarify the relevant content of the obligations of the two parties and the disposal measures for breach of contract。

Article 22 The third -party platform provider of the third -party platform of the medical device network transaction service shall record the medical device transaction information carried out on its platform，Records should be stored to 2 years after the effective period of medical equipment; if there is no validity period，The preservation time must not be less than 5 years; the transaction information of implant medical equipment should be permanently saved。Related records should be true、Full、traceable。

Article 23 The provider of the third -party platform of the medical device network transaction service shall monitor the sales behavior and information of the medical device on the platform，It is found that companies that settled in the third -party platform of online transaction services have existence of over -range operations、Release false information、Exaggerated publicity and other illegal acts、Unable to get in touch or there are other serious safety hazards，It should immediately stop the online transaction service of it，and save relevant records，Report to the provincial food and drug supervision and management department of the local area。
It is found that companies that settled in the third -party platform of online transaction services were ordered by the food and drug supervision and management department to stop production and suspension、Skill license My stake betting appand other punishment，or the product of the platform trading was suspended or sold by the food and drug supervision and management department，It should stop providing relevant network transaction services immediately。

Twenty -four medical device network transaction services third -party platform providers shall publish related information such as hidden quality and safety hazards in a prominent location on the website。

Chapter 4 Supervision and Inspection

Article 25 of the food and drug supervision and management department in accordance with the law、Regulations、Regulations on regulations，According to its power, the third -party platform of enterprises and medical device network transaction services engaged in medical device network sales in the third -party platform of medical device networks。

Article 26 The investigation and punishment of illegal behavior of enterprises engaged in online sales of medical device，Jurisdiction of the local food and drug supervision and management department at or above the county level of the county level。
Unauthorized or filed for medical device online sales，Can determine the address of illegal sales enterprise，The local food and drug supervision and management departments at or above the county level where the illegal sales enterprise is located;，The jurisdiction of the local food and drug supervision and management department at or above the county level at the place of illegal acts or the result of the result of illegal acts。Sale of third -party platforms through medical device network transactions，The provincial food and drug supervision and management department where the third -party platform provider of the medical device network trading service is located;，Timely transfer to the food and drug supervision and management department of jurisdiction。
Investigation and punishment of illegal behavior of the third -party platform provider of medical device network transaction services，The jurisdiction of the provincial food and drug supervision and management department of the local area。
A major quality accident occurred in the online sales of medical devices or causing other serious harmful consequences，Can be located from the location of the illegal enterprise、Where the illegal act of occurrence or the result of illegal acts, the provincial food and drug supervision and management department is under the jurisdiction of the provincial food and drug supervision and management department; the consequences are particularly serious，Provincial food and drug supervision and management departments can report to the State Food and Drug Administration to coordinate or organize directly to investigate and deal with it。
Website of illegal behavior of online sales of medical devices，The provincial food and drug supervision and management department notified the competent communication department at the same level。

27 The State Administration of Food and Drug Administration organizes the establishment of a national medical device network transaction monitoring platform，Carry out national medical device online sales and network transaction monitoring and disposal，Monitoring situation regularly reports the provincial food and drug supervision and management department。Suspected illegal information on monitoring illegal and illegal information，Timely transfer to relevant provincial food and drug supervision and management departments。Provincial food and drug supervision and management department shall organize processing in time。

Article 28 The provincial food and drug supervision and management department establishes the medical device network sales monitoring platform，Data docking should be implemented with the national medical device network transaction monitoring platform。

Article 29 Food and Drug Supervision and Management Department to carry out daily supervision and management of medical device network sales，or investigate and deal with the online sales behavior of suspected violations of laws and regulations，I have the right to take the following measures:
(1) Entering the business place of enterprise medical equipment、Organizing places and servers to implement on -site inspections;
(2) Sample testing of medical devices sold online;
(3) Ask relevant personnel，Investigating the relevant situation of the company's online sales behavior in the company;
(4) Check、Copy the transaction data of the enterprise、Contract、Bills、account books and other related information;
(V) Technical monitoring of online sales、Record information;
(6) Seal the seizure data storage medium in accordance with the law, etc.;
(7) Law、Other measures stipulated in the regulations。

Article 30 The sampling test for online sales of medical devices，Implementation of relevant management regulations in accordance with the quality supervision of medical equipment。
The test results do not meet the quality and safety standards of medical equipment，Food and Drug Supervision and Administration Department after receiving the inspection report，It should be supervised and inspected related production and operation enterprises in a timely manner，Take control measures，Release quality announcement in time，Investigate and deal with illegal acts in accordance with the law。

Article 31 The technical monitoring record of the online sales of medical device networks for food and drug supervision and management、Information traceability information, etc.，It can be used as the basis for identifying the facts of illegal facts of medical device online sales。

Article 32: The actual situation of the company engaged in the online sales of medical device networks is inconsistent with the filing information and cannot be contacted，After the city -level food and drug supervision and management department in which the place where the place is located 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。Related websites shall report by the provincial food and drug supervision and administration department to report at the same level of communication authorities。
The actual situation of the third -party platform provider of the medical device network transaction service is inconsistent with the filing information and cannot be contacted，After the provincial food and drug supervision and management department where the original filing is located, it is announced，Mark it in its filing information，Announcement to the society; the false information provided during the filing，Announcement of the filing unit from the provincial food and drug supervision and management department。Its website is reported by the provincial food and drug supervision and management department to report the authority of the same level of communication。

Article 33 The food and drug supervision and management department found that the third -party platform of enterprises or medical device network transaction services engaged in medical device online sales in the examination did not establish and implement the relevant quality management system in accordance with regulations，and there are hidden dangers of the quality and safety of medical equipment，Food and Drug Supervision and Administration Department may order it to suspend online sales or suspend related network transaction services。
Restore network sales or resume related network transaction services，Enterprises engaged in medical device online sales or medical device network transaction services third -party platform providers shall apply to the food and drug supervision and management department of the original processing decision，After inspection by the food and drug supervision and management department, it can be recovered after passing through。

Article 34 Enterprises engaged in online sales of medical device、Medical Devices Network Transaction Services Third -Party Platform Provider，There is one of the following circumstances，Food and Drug Supervision and Administration Department can interview their legal representatives or main responsible persons in accordance with their duties:
(1) Quality and safety of medical equipment，The quality and safety risk of medical equipment may be triggered;
(2) The quality of medical device quality reported in time and properly handle the complaint report，It may exist in the hidden dangers of quality and safety of medical equipment;
(3) Do not take effective measures to check in time、Eliminate the hidden dangers of quality and safety of medical equipment，If the quality and safety responsibility of the medical equipment is not implemented;
(4) Other situations that need to be interviewed.
The interview does not affect the food and drug supervision and management department to conduct administrative processing in accordance with the law，Interviews and subsequent treatment can be made public。
The interviewed by the company has no proper reasons that did not implement rectification in accordance with the requirements，Provincial food and drug supervision and management department、Municipal food and drug supervision and management departments in the place where you are located shall increase the frequency of supervision and inspection in accordance with responsibilities。

Article 35 There is one of the following situations，Food and Drug Supervision and Administration Department can sell companies engaged in the online sales of medical device、Medical Devices Network Transaction Services Third -Party Platform provider and its legal representative or main responsible persons are included in the list of dishonesty enterprises and credit persons，and make public public:
(1) If you refuse to implement the decision of suspension of online sales or suspend the provision of relevant network transaction services;
(2) The company refuses to rectify after being interviewed。

Article 36: The local food and drug supervision and management departments at or above the county level shall regularly analyze and analyze the supervision and management of medical device network sales in this administrative region，Report the previous level of food and drug supervision and management department，and disclose to the society in accordance with the law。
Provincial food and drug supervision and management department shall summarize the annual analysis of the supervision and management of the third -party platform of medical device online sales and network transaction services，Report the State Food and Drug Administration，and disclose to the society in accordance with the law。

Chapter 5 Legal Responsibility

Article 37 Enterprises engaged in online sales of medical device、Medical Device Network Transaction Services Third -Party Platform Provider illegal Sales or Trading Services，The provisions of laws and regulations existing，From its regulations。For the crime，Transfer to the public security organs for treatment。

Article 38 violates the provisions of these Measures，Unable to obtain medical device business licenses engaged in the sales of the third type of medical device，In accordance with the provisions of Article 63 of the Regulations on the Supervision and Administration of Medical Device;，Punishment in accordance with Article 65 of the Regulations on the Supervision and Administration of Medical Devices。

Article 39 Enterprises engaged in online sales of medical device do not be filed in accordance with the provisions of these Measures，from the local food and drug supervision and management department at or above the county level to order correction within a time limit，Give warning; refuse to correct，Announcement to the society，penalties below 10,000 yuan。

Article 40 There is one of the following situations，from the local food and drug supervision and management department at or above the county level or order to make corrections，Give warning; refuse to correct，Fined fines of 5,000 yuan or less than 10,000 yuan:
(1) Enterprises engaged in medical device online sales have not displayed medical device production and operation licenses or filing vouchers、Registration certificate or filing certificate of medical device;
(2) Medical Device Network Transaction Services Third -Party Platform provider failed to display the medical device network transaction service number of the third -party platform for the registration voucher number in accordance with these Measures.。

Article 41 There is one of the following situations，from the local food and drug supervision and management department at or above the county level or order to make corrections，Give warning; refuse to correct，Fined fines of 5,000 yuan or less than 20,000 yuan:
(1) Corporate filing information engaged in online sales of medical device networks changes，If it is not changed as required;
(2) Enterprises engaged in medical device network sales have not established and implemented the quality management system in accordance with regulations;
(3) Medical device network transaction service third -party platform provider records have not changed as required;
(4) Third -party platform providers of medical device network transaction services failing to set up quality and safety management institutions or quality and safety management personnel with quality and safety management personnel in accordance with the requirements;
(5) The provider of the third -party platform provider of the medical device network transaction service did not establish and implement the quality management system。

Article 42: The provider of the third -party platform provider of the medical device network transaction service is not filed in accordance with the provisions of these Measures，The provincial food and drug supervision and management department shall order correction within a time limit;，Announcement to the society，fines below 30,000 yuan。

Article 43 There is one of the following situations，from the local food and drug supervision and management department at or above the county level or order to make corrections，Give warning; refuse to correct，Fined fines of 10,000 yuan and less than 30,000 yuan:
(1) Enterprises engaged in online sales of medical device、Medical Device Network Transaction Services Third -Party Platform Conditions change，If you no longer meet the requirements of the prescribed requirements;
(2) Enterprises engaged in online sales of medical device、Medical Devices Network Transaction Services Third -Party Platform provider does not cooperate with the supervision and inspection of the food and drug supervision and management department，or refuse、concealment、Not as good as providing relevant materials and data。

Article 44 There is one of the following situations，from the local food and drug supervision and management department at or above the county level or order to make corrections，Fined fines of 10,000 yuan and less than 30,000 yuan:
(1) Enterprises engaged in online sales of medical device networks exceeded the scope of business scope;
(2) The wholesale enterprise of medical device wholesale enterprises sells to business enterprises without qualifications、Use unit。
Medical device retail companies sell non -consumer medical devices to consumers' personal，punishment shall be punished in accordance with the first paragraph of the previous paragraph。

Article 45 Enterprises engaged in online sales of medical device do not be transported in accordance with the medical device instructions and label labels、Storage of medical equipment，Punishment shall be punished in accordance with the provisions of Article 67 of the Regulations on the Supervision and Administration of Medical Devices。

Article 46 The staff responsible for supervising the online sales of medical equipment online sales will not perform their duties or abuse their powers、Attention、徇 徇，Executive responsibility for administrative responsibility in accordance with the law;，Transfer to judicial organs to investigate criminal liability。

Article 47 Medical Device Network Transaction Services Third -Party Platform Provided to provide medical device products or services to others、The loss of property，Affordable civil liability in accordance with the provisions of relevant laws and regulations。

Chapter 6 Affiliation

Article 48 The format of the filed certificate of the third -party platform for medical device network transaction services is uniformly formulated by the State Food and Drug Administration。
Medical Devices Network Transaction Services Third -Party Platform File Certificate Printed by the Provincial Food and Drug Supervision and Administration。
Medical Devices Network Transaction Services for the third -party platform filing voucher number is: (X) Word of online equipment platform [xxxx] No. XXXXX 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 to five X represents the 4 -digit record year;
Sixth to 10th x represents 5 digits of the 5 -digit filing flow.

Article 49 Medical Device Network Information Services in accordance with the "Administrative Measures for Internet Drug Information Services"。

Article 50: These Measures will be implemented from March 1, 2018。