Chapter I General Provisions

Article 1 These measures are formulated in accordance with the network security law of the people's Republic of China, the regulations on the supervision and administration of medical devices, the measures for the administration of Internet information services and other laws and regulations in order to strengthen the supervision and administration of online sales of medical devices and online trading services of medical devices and ensure the safety of public equipment.

Article 2 These Measures shall be observed in the online sales of medical devices, the provision of online trading services of medical devices and their supervision and administration 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 administration of national medical device online sales and medical device online trading services, and organizing the monitoring of national medical device online sales and online trading services.

The provincial food and drug administration department is responsible for the supervision and administration of medical device online trading services.

The local food and drug regulatory departments at or above the county level shall be responsible for the supervision and administration of the online sales of medical devices within their respective administrative regions.

Article 4 enterprises engaged in online sales of medical devices and third-party platform providers of online trading services of medical devices shall abide by the laws, regulations and norms 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 online sales of medical devices refer to the holders of medical device marketing licenses (i.e. medical device registrars or recorders, 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 online trading service refers to an enterprise that only provides Web space, virtual trading place, trading rules, transaction matching, electronic orders and other trading services in medical device online trading for both parties or multiple parties to carry out trading activities, and does not directly participate in the sales of medical devices.

Article 5 enterprises engaged in online sales of medical devices and third-party platform providers of online trading services of medical devices shall take technical measures to ensure the authenticity, integrity and traceability of online sales data and materials of medical devices.

Article 6 enterprises engaged in online sales of medical devices and third-party platform providers of online trading services of medical devices shall actively cooperate with the food and drug administration to carry out network monitoring, sampling inspection, on-site inspection and other supervision and management, store data according to the requirements of the food and drug administration, and provide information query, data extraction and other relevant support.

Chapter II network sales of medical devices

Article 7 an enterprise engaged in online sales of medical devices shall be a medical device production and operation enterprise that has obtained a medical device production license, business license or filed according to law. Except for those that do not need to apply for permission or filing according to laws and regulations.

If the holder sells its medical devices through the Internet, and the medical device manufacturing enterprise is entrusted by the holder to sell the entrusted medical devices through the Internet, it does not need to apply for business license or filing, and its sales conditions shall meet the requirements of the regulations on the supervision and administration of medical devices and these measures.

If the holder entrusts to carry out online sales of medical devices, it shall evaluate and confirm the legal qualification, sales conditions, technical level and quality management ability of the entrusted party, guide and supervise the online sales process and quality control, and be responsible for the quality of medical devices sold online.

Article 8 enterprises engaged in online sales of medical devices shall fill in the online sales information form of medical devices, and record the enterprise name, legal representative or main person in charge, website name, network client application name, website domain name, website IP address, telecom business operation license or non operational Internet information service filing number The number of medical device production and operation license or filing certificate shall be filed with the food and drug administration department at the municipal level divided into districts in advance. In case of any change in relevant information, the change shall be filed in a timely manner.

Article 9 enterprises engaged in online sales of medical devices shall carry out online sales of medical devices through self built websites or third-party platforms for online trading services of medical devices.

Enterprises that carry out online sales of medical devices through self built websites shall obtain the qualification certificate of Internet drug information service according to law, and have office space, data backup, fault recovery and other technical conditions suitable for their scale.

Article 10 an enterprise engaged in online sales of medical devices shall display its medical device production and operation license or Filing Certificate in a prominent position on its main page, and the product page shall display the medical device registration certificate or filing certificate of the product. Relevant display information shall be clear and easy to identify. Among them, the number of medical device production and operation license or filing certificate, medical device registration certificate or filing certificate shall also be displayed in the form of text. In case of any change in relevant information, the display content shall be updated in time.

Article 11 the name, model, specification, structure and composition, scope of application, number of medical device registration certificate or filing certificate, information of registrant or filing person, number of production license or filing certificate, number of product technical requirements, contraindications and other information published online by enterprises engaged in online sales of medical devices, It shall be consistent with the relevant contents registered or filed.

Article 12 enterprises engaged in online sales of medical devices shall record the sales information of medical devices, and the 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; The sales information of implantable medical devices shall be kept permanently. Relevant records shall be true, complete and traceable.

Article 13 the business scope of an enterprise engaged in online sales of medical devices shall not exceed the scope of its production and operation license or filing.

Medical device wholesale enterprises engaged in online sales of medical devices shall sell them to qualified medical device operating enterprises or users.

Medical device retail enterprises engaged in online sales of medical devices shall sell them to consumers. The medical devices sold to individual consumers shall be able to be used by individual consumers themselves, and their instructions shall comply with the relevant provisions on the instructions and label management of medical devices, with special instructions for safe use.

Article 14 enterprises engaged in online sales of medical devices shall store and transport medical devices in accordance with the conditions indicated in the labels and instructions of medical devices. Where other units are entrusted to store and transport medical devices, they shall assess the quality assurance ability of the entrusted party to store and transport medical devices, clarify the quality and safety responsibilities in the process of storage and transportation, and ensure the quality and safety in the process of storage and transportation.

Chapter III medical device online trading services

Article 15 the third-party platform provider of medical device online trading service shall obtain the qualification certificate of Internet drug information service according to law, have the office space suitable for its scale, data backup, fault recovery and other technical conditions, set up a special medical device network quality and safety management organization or equip medical device quality and safety management personnel.

Article 16 the third-party platform provider of medical device online trading service shall file with the local provincial food and drug administration department, fill in the filing form of the third-party platform of medical device online trading service, and submit the following materials:

（1） Original and copy of business license;

（2） The original and copy of the identity certificate of the legal representative or main person in charge and the quality and safety manager of medical devices;

（3） Organization and department setting description;

（4） The original and copy of the geographical location map of the office, the house property right certificate or the lease agreement (with the house property right certificate);

（5） The original and copy of the telecom business operation license or the filing instructions for non operational Internet information services;

（6） Original and copy of qualification certificate for Internet drug information service;

（7） Catalogue of documents such as medical device network transaction service quality management system;

（8） Basic information and function description of website or network client application;

（9） Other relevant supporting materials.

Article 17 the provincial food and drug regulatory department shall check the integrity of the materials submitted by the enterprise on the spot, file those that meet the provisions, and issue the Filing Certificate to the third-party platform of medical device online trading service; If the submitted materials are incomplete or do not comply with the statutory circumstances, the matters requiring supplementary materials shall be notified at one time.

The provincial food and drug administration department shall disclose the relevant filing information to the public within 7 working days after filing. The filing information includes the enterprise name, legal representative or main person in charge, website name, network client application name, website domain name, website IP address, telecom business license or non operational Internet information service filing number, medical device network transaction service third-party platform Filing Certificate number, etc.

The provincial food and drug regulatory department shall carry out on-site inspection on the third-party platform of medical device online trading service within 3 months after the provider of the third-party platform of medical device online trading service is filed.

Article 18 If the name, legal representative or main person in charge, website name, network client application name, website domain name, website IP address, telecom business license or non operational Internet information service filing number and other filing information of the third-party platform provider of medical device online trading service change, it shall change the filing information in time.

Article 19 the third-party platform provider of medical device online trading service shall mark the number of the filing voucher of the third-party platform of medical device online trading service in a prominent position on the main page of its website.

Article 20 the third-party platform provider of medical device online trading service shall establish management systems including enterprise verification and registration, quality and safety monitoring, transaction security, prevention and reporting of online sales violations, suspension of platform services for serious violations, handling of safety complaints, protection of consumers' rights and interests, announcement of quality and safety information, etc.

Article 21 the third-party platform provider of medical device online trading service shall verify the medical device production and operation license or filing certificate, medical device registration certificate or filing certificate, enterprise business license and other materials provided by the enterprise applying to settle in the platform, establish files and update them in time, Ensure the authenticity of the license or filing information such as production and business premises specified in the enterprise license or filing certificate settled on the platform.

The third-party platform provider of medical device online trading service shall sign a settlement agreement with the enterprises settled on the platform, and specify the obligations of both parties and default disposal measures in the agreement.

Article 22 the third-party platform provider of medical device online trading service shall record the medical device transaction information carried out on its platform, and the record shall be kept for 2 years after the validity of the medical device; If there is no validity period, the storage time shall not be less than 5 years; The transaction information of implantable medical devices shall be kept permanently. Relevant records shall be true, complete and traceable.

Article 23 the third-party platform provider of medical device online trading service shall monitor the sales behavior and information of medical devices on the platform, and find that the enterprises settled in the third-party platform of online trading service have violations of laws and regulations such as beyond the scope of business, publishing false information, exaggerated publicity, unable to get in touch or other serious potential safety hazards, It shall immediately stop its online trading services, keep relevant records and report to the local provincial food and drug administration.

If it is found that the enterprises settled on the third-party platform of online trading services are ordered by the food and drug administration to stop production and business, revoke their licenses and other penalties, or the products traded on the platform are suspended or stopped by the food and drug administration, the provision of relevant online trading services shall be stopped immediately.

Article 24 the third-party platform provider of medical device online trading service shall timely publish relevant information such as hidden dangers of product quality and safety in an eye-catching position on the website.

Chapter IV Supervision and inspection

Article 25 the food and drug regulatory department shall, in accordance with the provisions of laws, regulations and rules, supervise, inspect and sample the enterprises engaged in online sales of medical devices and the third-party platform of online trading services of medical devices.

Article 26 the investigation and punishment of illegal acts of enterprises engaged in online sales of medical devices shall be under the jurisdiction of the local food and drug administration at or above the county level.

If an enterprise engaged in online sales of medical devices without permission or filing can determine the address of the illegal sales enterprise, it shall be under the jurisdiction of the local food and drug regulatory department at or above the county level in the place where the illegal sales enterprise is located; If the location of the illegal sales enterprise cannot be determined, it shall be under the jurisdiction of the local food and drug administration at or above the county level where the illegal act occurs or where the illegal act results. Those sold through the third-party platform of medical device online trading service shall be under the jurisdiction of the provincial food and drug administration department where the third-party platform provider of medical device online trading service is located; If the jurisdiction can be determined after investigation, it shall be transferred to the food and drug supervision and administration department with jurisdiction in time.

The investigation and punishment of the illegal acts of the third-party platform providers of medical device online trading services shall be under the jurisdiction of the local provincial food and drug administration.

If a major quality accident or other serious harmful consequences occur to the medical devices sold online, it may be under the jurisdiction of the provincial food and drug administration department where the illegal enterprise is located, where the illegal act occurs or where the illegal act results; If the consequences are particularly serious, the provincial food and drug administration may report to the State Food and Drug Administration for coordination or organize direct investigation and punishment.

The provincial food and drug supervision and administration department shall notify the competent communication department at the same level of the website where the illegal act of online sales of medical devices occurs.

Article 27 The State Food and drug administration shall organize the establishment of a national online transaction monitoring platform for medical devices, carry out the monitoring and disposal of national online sales and online transactions of medical devices, and regularly report the monitoring results to the provincial food and drug administration. The information suspected of violating laws and regulations found in the monitoring shall be timely transmitted to the relevant provincial food and drug supervision and administration departments. The provincial food and drug regulatory department shall organize the handling in time.

Article 28 the online sales monitoring platform of medical devices established by the provincial food and drug regulatory department shall realize data docking with the national online transaction monitoring platform of medical devices.

Article 29 when the food and drug administration carries out the daily supervision and administration of online sales of medical devices, or investigates and deals with the online sales of medical devices suspected of violating laws and regulations, it has the right to take the following measures:

（1） Enter the enterprise's medical device business place, office place and server location for on-site inspection;

（2） Conduct sampling inspection on medical devices sold online;

（3） Ask relevant personnel to investigate the relevant situation of enterprises engaged in online sales of medical devices;

（4） View and copy the enterprise's transaction data, contracts, bills, account books and other relevant materials;

（5） Obtain technical monitoring and recording data of online sales;

（6） Sealing up and detaining data storage media according to law;

（7） Other measures that can be taken according to laws and regulations.

Article 30 the sampling inspection of medical devices sold online shall be implemented in accordance with the relevant management regulations on quality supervision, random inspection and inspection of medical devices.

If the inspection results do not meet the quality and safety standards of medical devices, the food and drug regulatory department shall, after receiving the inspection report, timely carry out supervision and inspection on relevant production and trading enterprises, take control measures, timely issue Quality announcements, and investigate and deal with illegal acts according to law.

Article 31 the technical monitoring records and information traceability materials of the food and drug regulatory department for the online sales of medical devices can be used as the basis for determining the illegal facts of the online sales of medical devices.

Article 32 If the actual situation of an enterprise engaged in online sales of medical devices is inconsistent with the filing information and cannot be contacted, its medical device business license shall be cancelled according to law or in Category II after being publicized by the local municipal food and drug regulatory department divided into districts