CFDA Enacts 'Measures for Supervision and Administration of Online Sales of Medical Devices,' Requiring Physical Stores and Product Transparency

VCBeat (WeChat ID: vcbeat) has learned, on December 22, 2017, in order to strengthen the supervision and administration of online sales of medical devices and online transaction services for medical devices, and to ensure the safety of medical device use by the public, the China Food and Drug Administration formulated and promulgated《Measures for the Supervision and Administration of Online Sales of Medical Devices》(hereinafter referred to as the “Measures”), which shall come into effect onEffective March 1, 2018。

The Measures adhere toOnline-Offline Consistencythe principle that medical device manufacturers, distributors, and marketing authorization holders engaged in online sales shall meet the requirements stipulated in the Regulations on the Supervision and Administration of Medical Devices and the Measures;Third-party providers of online transaction services shall verify and confirm that enterprises operating on their platforms maintain physical brick-and-mortar stores.

The Measures require online sales enterprises and third-party platform providers for online transaction services to respectivelyFile with the Municipal Bureau and the Provincial Bureau, and further specified the obligations of online sales enterprises and third-party platform providers for online transaction services, stipulating that online sales enterprises shallEnsuring the Quality and Safety of Medical Devices; Third-party platform providers shall establish a system for enterprises entering the platformVerification and Registration, Quality and Safety Monitoringsuch management systems, immediately suspend online transaction services for illegal operators and products and report them; online sales enterprises and third-party platform providers shallEnsure the authenticity, integrity, and traceability of sales transaction data and records.

The Measures clearly stipulateThird-party platform providers shall be uniformly regulated by the provincial-level food and drug administration departments.In light of the cross-regional nature of online sales and the wide-reaching impact of quality issues, the Measures specify the investigative responsibilities for different types of online violations, fostering coordinated collaboration among regulatory authorities at all levels in the jurisdictions where the violating enterprise is located, where the illegal act occurred, and where the consequences of the illegal act manifested. For violations with particularly serious consequences, a request may be submitted to the State Administration for coordination, or the State Administration may organize and conduct direct investigations. The Measures stipulate that the State AdministrationEstablish a National Online Transaction Monitoring Platform, regularly report monitoring findings to the provincial bureau; local regulatory authorities shall regularly submit reports to the State Administration and disclose such information to the public in accordance with the law.

The Measures strengthen risk control. For entities that fail to establish and implement relevant quality management systems in accordance with regulations, thereby posing quality and safety hazards, regulatory authorities may order the suspension of online sales or the provision of related online transaction services. In cases involving quality and safety issues, food and drug regulatory authorities may conduct regulatory interviews with the legal representatives or principal persons in charge of third-party platform providers and online selling enterprises. Those who refuse to comply with orders to suspend online sales, or fail to carry out rectification as required following such interviews, will have their enterprises (including online sellers and third-party platform providers) and their legal representatives or principal persons in charge listed on the lists of dishonest enterprises and individuals, and such information shall be disclosed to the public.

As the “Internet Plus” initiative continues to advance, the integration of the medical device industry with the internet is accelerating, and online sales of medical devices are becoming increasingly active.

In recent years, the state has successively introduced a series of policies to further reduce institutional and mechanistic barriers hindering the development of e-commerce. Meanwhile, issues such as the online sale of counterfeit and substandard medical devices, false and exaggerated advertising, and consumer fraud have continued to emerge. For instance, illegal sales of unregistered medical device products and the dissemination of unlawful and non-compliant information frequently occur on e-commerce platforms, direct-operated websites, or mobile clients, posing potential risks to the safety of medical device use by the public. Furthermore, due to the virtual, cross-regional, concealed, and easily transferable nature of online sales, numerous challenges have arisen, including unclear regulatory jurisdiction, lagging regulatory methods, difficulties in investigation and evidence collection, and insufficient legal bases for law enforcement.

Therefore, improving the regulations related to online sales of medical devices, and further clarifying the main responsibilities and regulatory duties from an institutional perspective, is of great significance for strengthening supervision methods and measures, continuously standardizing business practices, and severely cracking down on illegal activities in the online sale of medical devices.

Accordingly, in accordance with the Cybersecurity Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, and other relevant laws and regulations, and taking into account the General Office of the Communist Party of China Central Committee and the General Office of the State Council’s Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices, as well as the practical needs of regulatory oversight over online sales of medical devices, the China Food and Drug Administration has formulated these Measures.

The Measures consist of 50 articles, covering the legislative purpose, scope of application, obligations of enterprises engaged in online sales of medical devices and third-party platform providers for online medical device transaction services, as well as supervision and administration, and legal liabilities.

The Measures clarify"Consistency Between Online and Offline"Principles,FromEnterprises engaged in the online sales of medical devices, the applicant shall be a physical medical device manufacturing or operating enterprise that has legally obtained a medical device production license, operation license, or completed filing, as well as a medical device marketing authorization holder (i.e., medical device registrant or filer) whose sales conditions comply with the requirements of the Regulations on the Supervision and Administration of Medical Devices and the Measures. The operational model shall involve selling medical devices through self-built websites (including web client applications) or third-party platforms for online medical device transaction services.

Third-Party Platform Provider for Online Trading Services of Medical Devices, refers to enterprises that, in online medical device transactions, only provide transaction services such as web space, virtual trading venues, transaction rules, transaction matching, and electronic orders, for two or more parties to conduct trading activities, without directly participating in the sale of medical devices.

Furthermore, the Measures explicitly stipulate thatOnline information services for medical devices shall be implemented in accordance with the "Administrative Measures for Internet Drug Information Services."Therefore, enterprises engaged in the online sales of medical devices through self-built websites and third-party platform providers for online medical device transactions shall obtain the Internet Drug Information Service Qualification Certificate in accordance with the Measures for the Administration of Internet Drug Information Services.

First, fulfill the filing obligations.Enterprises engaged in the online sale of medical devices shall file with the municipal-level food and drug administration authority in their locality at the level of a city divided into districts. Where any changes occur in the relevant filing information, they shall promptly update such information. Providers of third-party platforms for online medical device trading services shall file with the provincial-level food and drug administration authority in their locality. Where any changes occur in the relevant filing information, they shall promptly update the filing.

Second, establish systems related to quality management of medical devices.Third-party platform providers for online medical device transactions shall establish and implement management systems covering verification and registration of medical device manufacturers and distributors onboarding the platform, quality and safety monitoring, transaction security assurance, prevention and reporting of illegal online sales activities, suspension of platform services for serious violations, handling of safety-related complaints and reports, consumer rights protection, and public announcements of quality and safety information.

3. Obligation to Review and Register.Third-party platform providers for online medical device transactions shall verify and register the materials submitted by medical device manufacturers and distributors applying to join the platform, including medical device production and operation licenses or filing certificates, medical device registration certificates or filing certificates, and business licenses; establish and timely update archives; and execute entry agreements with such entities, clearly specifying mutual obligations, measures for handling breaches of contract, and other relevant terms.

Fourth, the relevant requirements for qualifications, premises, technical conditions, and management personnel.Enterprises engaged in the online sales of medical devices and third-party platform providers for online medical device transactions shall obtain the “Certificate of Qualification for Internet Drug Information Services” in accordance with the law, possess office premises commensurate with their scale as well as technical conditions such as data backup and failure recovery, and establish a dedicated medical device online quality and safety management department or appoint medical device quality and safety management personnel.

5. Platform Management Obligations.Third-party platform providers for online medical device transactions shall monitor the sales activities and information of medical devices on their platforms. Upon discovering any illegal conduct by medical device manufacturers or distributors operating on the third-party online transaction service platform, they shall immediately suspend online transaction services for such entities, retain relevant records, and report to the provincial-level food and drug administration authority in their locality. Where medical device manufacturers or distributors operating on the third-party online transaction service platform are ordered by the food and drug administration authorities to suspend production or business operations, or have their licenses revoked, the platform provider shall immediately cease providing online transaction services to them.

6. Duty to Keep Records.Enterprises engaged in the online sale of medical devices and third-party platform providers for online medical device transactions shall record transaction information. Such records shall be retained until two years after the expiration date of the medical device; for devices without an expiration date, the retention period shall be no less than five years; and transaction information for implantable medical devices shall be retained permanently. Technical measures shall be implemented to ensure that data and materials related to the online sale of medical devices are authentic, complete, secure, and traceable.

The scope of online business operations for medical devices shall not exceed the scope permitted by their production and operation licenses or filings.。Wholesale enterprises of medical devices engaged in online sales shall sell such devices only to qualified medical device distributors or user entities. Retail enterprises of medical devices engaged in online sales shall sell such devices exclusively to individual consumers. Medical devices sold to individual consumers must be suitable for self-use by consumers, and their instructions for use shall comply with relevant regulations on the administration of medical device instructions and labeling, including specific notes on safe usage. Medical devices intended for use by medical institutions shall not be sold to individuals.

Enterprises engaged in the online sale of medical devices shall store and transport such devices in accordance with the conditions specified on their labels and instructions for use. Where storage and transportation are entrusted to other entities, the entrusting party shall assess and evaluate the quality assurance capabilities of the entrusted party regarding the storage and transportation of medical devices, clearly define quality responsibilities during these processes, and ensure the quality and safety of the medical devices throughout storage and transportation.

ChinaThe China Food and Drug Administration is responsible for guiding the supervision and administration of online medical device sales and third-party platforms providing online transaction services for medical devices across China, and for organizing and conducting nationwide monitoring of online medical device sales.Provincial LevelThe food and drug regulatory authorities are responsible for the supervision and administration of third-party platforms providing online transaction services for medical devices.County-levelThe local food and drug administration departments are responsible for the supervision and management of online medical device sales within their respective administrative regions.

Where the food and drug supervision and administration authorities, during inspections, discover that enterprises engaged in online sales of medical devices or third-party platforms providing online transaction services for medical devices have failed to establish and implement relevant quality management systems as required, and where there are potential risks to the quality and safety of medical devices, they mayOrder it to suspend online sales or suspend the provision of related online transaction services。

Where enterprises engaged in online sales of medical devices or third-party platforms providing online transaction services for medical devices are found to have issues related to the quality and safety of medical devices, which may pose risks to such quality and safety, it is permissible toConduct regulatory interviews with their legal representatives or principal persons in charge, as required by their duties.

In addition, for medical devices that cause harm to the human body or for which there is evidence proving they may endanger human health, the Regulations on the Supervision and Administration of Medical Devices clearly stipulate that the food and drug regulatory authorities may takeEmergency control measures to suspend production, importation, distribution, and use.

The Measures not only clarify the legal liabilities of enterprises engaged in online sales of medical devices and third-party platform providers for online medical device transaction services, but also stipulate punitive measures against relevant responsible persons. For online sales enterprises or third-party platform providers for online medical device transaction services that refuse to suspend online sales or related online transaction services as required, or fail to implement rectification measures as required after being summoned for regulatory talks, the food and drug administration departments may include their legal representatives or principal persons in charge in the list of dishonest enterprises and individuals, and disclose such information to the public.

Order of the China Food and Drug Administration

No. 38

The Measures for the Supervision and Administration of Online Sales of Medical Devices were reviewed and approved at the executive meeting of the China Food and Drug Administration on November 7, 2017, and are hereby promulgated, effective as of March 1, 2018.

Director: Bi Jingquan

December 20, 2017

Measures for the Supervision and Administration of Online Sales of Medical Devices

Chapter I General Provisions

Article 1These Measures are formulated to strengthen the supervision and administration of online sales of medical devices and online transaction services for medical devices, safeguard the safety of public use of medical devices, in accordance with the Cybersecurity Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for Internet Information Services, and other laws and regulations.

Article 2Those engaged in the online sale of medical devices, the provision of online transaction services for medical devices, and the supervision and administration thereof within the territory of the People's Republic of China shall comply with these Measures.

Article 3The China Food and Drug Administration is responsible for guiding the supervision and administration of online medical device sales and online medical device transaction services nationwide, and for organizing and conducting monitoring of online medical device sales and transaction services across China.
　　

Provincial-level food and drug regulatory authorities are responsible for the supervision and administration of online trading services for medical devices.
　　

Local food and drug supervision and administration departments at or above the county level are responsible for the supervision and administration of online medical device sales within their respective administrative areas.

Article 4Enterprises engaged in the online sale of medical devices and third-party platform providers for online medical device transaction services shall comply with medical device laws, regulations, and standards, establish and improve management systems, operate with integrity in accordance with the law, and ensure the quality and safety of medical devices.
　　

Enterprises engaged in the online sales of medical devices refer to marketing authorization holders for medical devices (i.e., medical device registrants or filers, hereinafter referred to as “Holders”) and medical device manufacturing and trading enterprises that sell medical devices via the internet.
　　

Third-party platform providers for online medical device transaction services refer to enterprises that, in online medical device transactions, solely provide transaction services such as web space, virtual trading venues, transaction rules, transaction matching, and electronic orders to facilitate trading activities between two or more parties, without directly participating in the sale of medical devices.

Article 5Enterprises engaged in the online sale of medical devices and third-party platform providers for online medical device transactions shall adopt technical measures to ensure the authenticity, integrity, and traceability of data and records related to the online sale of medical devices.

Article 6Enterprises engaged in the online sale of medical devices and third-party platform providers for online medical device transactions shall actively cooperate with food and drug regulatory authorities in carrying out supervisory and administrative activities, including online monitoring, sampling inspections, and on-site inspections. They shall store data and provide relevant support, such as information inquiries and data extraction, in accordance with the requirements of the food and drug regulatory authorities.

Chapter 2 Online Sales of Medical Devices

Article 7Enterprises engaged in the online sale of medical devices shall be medical device manufacturers or distributors that have lawfully obtained a production license, an operation license, or completed filing. Exceptions apply where laws and regulations stipulate that no license or filing is required.
　　

Where a registrant sells its medical devices online, or a medical device manufacturer, entrusted by the registrant, sells the medical devices it manufactured under contract online, no operation license or filing is required; however, their sales conditions shall comply with the requirements of the Regulations on the Supervision and Administration of Medical Devices and these Measures.
　　

Where a registrant or filer entrusts the online sales of medical devices, it shall evaluate and confirm the trustee’s legal qualifications, sales conditions, technical capabilities, and quality management capacity; provide guidance and supervision over the online sales process and quality control; and assume responsibility for the quality of medical devices sold online.

Article 8Enterprises engaged in the online sale of medical devices shall complete the Medical Device Online Sales Information Form and file it in advance with the municipal-level food and drug administration authority in the districted city where they are located. The information to be filed includes the enterprise name, legal representative or principal person in charge, website name, name of the network client application, website domain name, website IP address, license for value-added telecommunications services or record-filing number for non-commercial internet information services, and the license or record-filing certificate number for medical device production or operation. In the event of any changes to the aforementioned information, the filing shall be updated promptly.

Article 9Enterprises engaged in the online sale of medical devices shall conduct such sales activities through their self-built websites or third-party platforms providing online transaction services for medical devices.
　　

Enterprises conducting online sales of medical devices through their self-built websites shall obtain the “Certificate for Internet Drug Information Services” in accordance with the law, and possess office premises commensurate with their scale as well as technical conditions such as data backup and failure recovery.

Article 10Enterprises engaged in the online sales of medical devices shall prominently display their Medical Device Production and Operation License or filing certificate on a conspicuous position of their homepage. The product page shall display the Medical Device Registration Certificate or filing certificate for the respective product. All displayed information shall be clear and easily identifiable. Among these, the license/certificate numbers of the Medical Device Production and Operation License or filing certificate, as well as the Medical Device Registration Certificate or filing certificate, shall also be presented in text format. In the event of any changes to the relevant information, the displayed content shall be updated promptly.

Article 11Enterprises engaged in the online sale of medical devices shall ensure that information published online, including the name, model, specification, structure and composition, intended use, medical device registration certificate number or record-filing voucher number, registrant or record-filer information, production license number or record-filing voucher number, product technical requirement number, and contraindications, is consistent with the content approved during registration or record-filing.

Article 12Enterprises engaged in the online sale of medical devices shall record sales information. Such records shall be retained for at least two years after the expiration of the medical device’s validity period; for devices without a specified validity period, the retention period shall be no less than five years; and sales information for implantable medical devices shall be retained permanently. All relevant records must be authentic, complete, and traceable.

Article 13Enterprises engaged in the online sale of medical devices shall not operate beyond the scope permitted by their production and operation licenses or filings.
　　

Medical device wholesale enterprises engaged in online sales of medical devices shall sell only to qualified medical device distributors or user entities.
　　

Medical device retailers engaged in online sales of medical devices shall sell such products to consumers. Medical devices sold to individual consumers must be suitable for self-use by the consumer, and their instructions for use shall comply with relevant regulations on the management of medical device instructions and labeling, including specific instructions for safe use.

Article 14Enterprises engaged in the online sale of medical devices shall store and transport such devices in accordance with the conditions specified on their labels and instructions for use. Where storage and transportation are entrusted to other entities, the entrusting party shall assess and evaluate the quality assurance capabilities of the entrusted party regarding the storage and transportation of medical devices, clearly define quality and safety responsibilities during these processes, and ensure the quality and safety of the medical devices throughout storage and transportation.

Chapter 3 Online Transaction Services for Medical Devices

Article 15Third-party platform providers for online medical device trading services shall obtain the “Certificate of Qualification for Internet Drug Information Services” in accordance with the law, possess office premises commensurate with their scale as well as technical conditions such as data backup and failure recovery, and establish a specialized agency for medical device online quality and safety management or appoint personnel responsible for medical device quality and safety management.

Article 16Third-party platform providers for online medical device transactions shall file with the provincial-level food and drug administration in their locality, complete the Filing Form for Third-Party Platforms Providing Online Medical Device Transaction Services, and submit the following materials:
　　

(i) Original and photocopy of the Business License;
　　

(2) Original and photocopies of the identity documents of the legal representative or principal person in charge, and the medical device quality and safety manager;
　　

(III) Description of Organizational Structure and Departmental Setup;
　　

(4) Original and photocopy of the geographical location map of the office premises, property ownership certificate, or lease agreement (with attached property ownership certificate);
　　

(5) Original and copy of the Telecommunications Business Operation License, or a filing statement for non-commercial internet information services;

(6) Original and photocopy of the "Internet Drug Information Service Qualification Certificate";
　　

(VII) Catalogue of documents such as the quality management system for medical device online transaction services;
　　

(8) Basic introduction and functional description of the website or web client application;
　　

(9) Other relevant supporting documents.

Article 17The provincial-level food and drug administration shall verify the completeness of the materials submitted by the enterprise on the spot; if the materials comply with the regulations, they shall be recorded and a Certificate of Record for Third-Party Platforms Providing Online Transaction Services for Medical Devices shall be issued. If the submitted materials are incomplete or do not meet the statutory requirements, the applicant shall be informed in one go of the matters requiring supplementary materials.
　　

Provincial-level food and drug administration departments shall disclose the relevant filing information to the public within seven working days after the filing. The filing information includes the enterprise name, legal representative or principal responsible person, website name, name of the network client application, website domain name, website IP address, telecommunications business operation license or non-commercial internet information service filing number, and filing certificate number for third-party platforms providing online transaction services for medical devices, etc.
　　

Provincial-level food and drug regulatory authorities shall conduct on-site inspections of third-party platforms providing online transaction services for medical devices within three months after the filing of such platform providers.

Article 18Where there are changes to the filing information of a third-party platform provider for online trading services of medical devices, such as its name, legal representative or principal responsible person, website name, name of the web client application, website domain name, website IP address, and telecommunications business operation license number or non-commercial internet information service filing number, it shall promptly update its filing.

Article 19Third-party platform providers for online medical device transaction services shall display the registration certificate number of the third-party platform for online medical device transaction services in a prominent position on the homepage of their website.

Article 20Third-party platform providers for online medical device transactions shall establish management systems covering verification and registration of enterprises onboarding the platform, quality and safety monitoring, transaction security assurance, prevention and reporting of illegal online sales activities, suspension of platform services for serious violations, handling of safety-related complaints and reports, protection of consumer rights and interests, and public announcement of quality and safety information.

Article 21Third-party platform providers for online medical device transactions shall verify the materials submitted by enterprises applying to join the platform, including Medical Device Production and Operation Licenses or filing certificates, Medical Device Registration Certificates or filing certificates, and business licenses; establish and timely update archives thereof; and ensure the authenticity of the licensed or filed information, such as the production and operation premises, stated on the licenses or filing certificates of the enterprises joining the platform.
　　

Third-party platform providers for online medical device trading services shall enter into onboarding agreements with enterprises listed on the platform, and clearly specify in such agreements the obligations of both parties and measures for handling breaches of contract, among other relevant matters.

Article 22Third-party platform providers for online medical device transactions shall record transaction information conducted on their platforms. Such records shall be retained for at least two years after the expiration of the medical device’s validity period; if no validity period is specified, the retention period shall be no less than five years; transaction information for implantable medical devices shall be retained permanently. Relevant records shall be authentic, complete, and traceable.

Article 23Third-party platform providers for online medical device transaction services shall monitor the sales activities and information of medical devices on their platforms. If they discover that enterprises registered on the third-party online transaction service platform are engaged in illegal or non-compliant activities such as operating beyond their approved scope, publishing false information, or making exaggerated claims, or if such enterprises cannot be contacted or pose other serious safety hazards, the platform providers shall immediately suspend their online transaction services, retain relevant records, and report to the provincial-level food and drug administration authority where the platform provider is located.
　　

Where an enterprise operating on a third-party online transaction service platform is subject to administrative penalties imposed by the food and drug regulatory authorities, such as orders to suspend production or business operations, or revocation of licenses; or where products traded on the platform are ordered to be suspended from sale or removed from sale by the food and drug regulatory authorities, the platform shall immediately cease providing relevant online transaction services.

Article 24Third-party platform providers for online trading services of medical devices shall promptly publish information on product quality and safety hazards in a prominent position on their websites.

Chapter 4 Supervision and Inspection

Article 25Food and drug regulatory authorities shall, in accordance with the provisions of laws, regulations, and rules, conduct supervisory inspections and sampling tests on enterprises engaged in online sales of medical devices and third-party platforms for online medical device transaction services, pursuant to their statutory authority.

Article 26Investigation and handling of illegal acts committed by enterprises engaged in the online sales of medical devices shall fall under the jurisdiction of the local food and drug administration at or above the county level in the place where the enterprise is located.
　　

For unauthorized online sales of medical devices without permission or filing, if the address of the violating enterprise can be determined, jurisdiction shall lie with the local food and drug administration at or above the county level in the place where the violating enterprise is located; if the location of the violating enterprise cannot be determined, jurisdiction shall lie with the local food and drug administration at or above the county level in the place where the illegal act occurred or where its consequences resulted. For sales conducted through third-party platforms for online medical device transaction services, jurisdiction shall lie with the provincial-level food and drug administration in the place where the provider of such third-party platform is located; if the competent authority can be determined after investigation, the case shall be promptly transferred to the food and drug administration with proper jurisdiction.
　　

Jurisdiction over the investigation and handling of illegal acts committed by third-party platform providers for online medical device transactions shall rest with the provincial-level food and drug administration where the provider is located.
　　

In the event that medical devices sold online cause a major quality accident or result in other serious harmful consequences, jurisdiction may be exercised by the provincial-level food and drug administration authorities at the location of the violating enterprise, the place where the illegal act occurred, or the place where the consequences of the illegal act manifested. Where the consequences are particularly severe, the provincial-level food and drug administration authorities may request the China Food and Drug Administration to coordinate or directly organize investigation and enforcement actions.
　　

For websites involved in illegal online sales of medical devices, the provincial-level food and drug administration shall notify the communications authority at the same level.

Article 27The China Food and Drug Administration shall organize the establishment of a national online transaction monitoring platform for medical devices, carry out nationwide monitoring and handling of online sales and transactions of medical devices, and regularly report the monitoring results to provincial-level food and drug regulatory authorities. Information suspected of violating laws and regulations identified through monitoring shall be promptly transferred to the relevant provincial-level food and drug regulatory authorities, which shall organize timely handling.

Article 28Provincial-level food and drug regulatory authorities shall ensure that the medical device online sales monitoring platforms they independently establish are integrated with the National Medical Device Online Transaction Monitoring Platform for data exchange.

Article 29When conducting routine supervision and administration of online medical device sales, or investigating and handling suspected illegal or non-compliant activities in the online sale of medical devices, the food and drug regulatory authorities shall have the authority to take the following measures:
　　

(1) Conduct on-site inspections at the enterprise’s medical device business premises, office locations, and server sites;
　　

(2) Conduct sampling inspections of medical devices sold online;
　　

(3) Interview relevant personnel to investigate the circumstances related to the enterprise’s engagement in online sales of medical devices;
　　

(4) Review and copy the enterprise’s transaction data, contracts, invoices, account books, and other relevant materials;
　　

(5) Retrieve technical monitoring and record data related to online sales;
　　

(6) Seizing and detaining data storage media and other items in accordance with the law;
　　

(7) Other measures that may be taken as stipulated by laws and regulations.

Article 30Sampling inspections of medical devices sold online shall be conducted in accordance with the relevant administrative provisions on supervisory spot checks and testing of medical device quality.
　　

Where test results fail to meet the quality and safety standards for medical devices, the food and drug regulatory authorities shall, upon receipt of the test report, promptly conduct supervisory inspections of the relevant manufacturing and operating enterprises, implement control measures, issue quality announcements in a timely manner, and investigate and deal with illegal acts in accordance with the law.

Article 31Technical monitoring records and information traceability data on online medical device sales, maintained by the food and drug supervision and administration departments, may serve as evidence for establishing facts of illegal activities in online medical device sales.

Article 32Where an enterprise engaged in the online sale of medical devices is found to have actual circumstances inconsistent with its filed information and cannot be contacted, the municipal-level food and drug administration authority of the districted city where it is located shall, after public notice, cancel its Medical Device Operation License in accordance with the law or annotate such discrepancy in the filing information for Class II medical device operations, and announce this to the public. The relevant websites shall be reported by the provincial-level food and drug administration authority to the communications administrative department at the same level.
　　

Where the actual circumstances of a third-party platform provider for online medical device trading services are inconsistent with its filed information and the provider cannot be contacted, the provincial food and drug administration department at the place of original filing shall publicly display this discrepancy, annotate it in the filed information, and issue a public announcement to society. If false materials were provided during the filing process, the provincial food and drug administration department shall publicly announce the name of the filing entity to society. The provincial food and drug administration department shall notify the communications regulatory authority at the same level regarding the entity’s website.

Article 33Where, during inspections, food and drug regulatory authorities discover that enterprises engaged in online sales of medical devices or third-party platforms providing online transaction services for medical devices have failed to establish and implement relevant quality management systems as required, and where there are potential quality and safety risks associated with the medical devices, the food and drug regulatory authorities may order them to suspend online sales or suspend the provision of relevant online transaction services.
　　

Enterprises engaged in online sales of medical devices or third-party platform providers for online medical device transaction services that seek to resume online sales or the provision of related online transaction services shall submit an application to the food and drug administration department that originally made the administrative decision. Resumption is permitted only after passing inspection by said department.

Article 34Where an enterprise engaged in the online sale of medical devices or a third-party platform provider for online medical device transactions commits any of the following acts, the food and drug regulatory authority may, within the scope of its duties, conduct a regulatory interview with its legal representative or principal person in charge:
　　

(1) Where medical device quality and safety issues occur, which may give rise to medical device quality and safety risks;
　　

(2) Failure to handle complaints and reports regarding medical device quality issues in a timely and appropriate manner, which may pose potential safety hazards related to the quality of medical devices;
　　

(3) Failure to take timely and effective measures to identify and eliminate quality and safety hazards of medical devices, or failure to fulfill responsibilities for the quality and safety of medical devices;
　　

(4) Other circumstances requiring an interview.
　　

Regulatory interviews shall not preclude the food and drug administration departments from imposing administrative penalties in accordance with the law. Information regarding such interviews and subsequent actions may be disclosed to the public.
　　

Where an enterprise that has been summoned for a regulatory talk fails to implement corrective measures as required without justifiable reasons, the provincial food and drug administration and the municipal food and drug administration of the districted city where the enterprise is located shall, in accordance with their respective duties, increase the frequency of supervisory inspections.

Article 35Where any of the following circumstances exist, the food and drug administration authorities may include enterprises engaged in online sales of medical devices, third-party platform providers for online medical device transaction services, and their legal representatives or principal persons in charge on the list of dishonest enterprises and individuals, and disclose such information to the public:
　　

(1) Refusing to comply with the decision to suspend online sales or suspend the provision of relevant online transaction services;
　　

(II) The enterprise refuses to make corrections as required after being summoned for a regulatory interview.

Article 36Local food and drug administration departments at or above the county level shall regularly compile and analyze the supervision and administration of online medical device sales within their respective administrative areas, report to the next higher-level food and drug administration department, and disclose such information to the public in accordance with the law.
　　

Provincial-level food and drug regulatory authorities shall annually compile and analyze the supervision and administration of online medical device sales and third-party platforms for online transaction services, report to the China Food and Drug Administration, and disclose such information to the public in accordance with the law.

Chapter V Legal Liability

Article 37Enterprises engaged in the online sale of medical devices and third-party platform providers for online medical device transaction services that violate relevant laws and regulations by engaging in sales or transaction services shall be subject to the provisions of such laws and regulations where applicable. Where a crime is constituted, the case shall be transferred to public security organs for handling.

Article 38Where any entity engages in the online sale of Class III medical devices without obtaining a medical device operation license, in violation of these Measures, it shall be penalized in accordance with Article 63 of the Regulations on the Supervision and Administration of Medical Devices; where any entity engages in the online sale of Class II medical devices without obtaining the filing certificate for Class II medical device operation, it shall be penalized in accordance with Article 65 of the Regulations on the Supervision and Administration of Medical Devices.

Article 39Enterprises engaged in the online sale of medical devices that fail to file records in accordance with these Measures shall be ordered by the food and drug administration departments at or above the county level to make corrections within a specified time limit and given a warning; those that refuse to make corrections shall be publicly announced to the society and fined less than RMB 10,000.

Article 40Where any of the following circumstances occurs, the local food and drug administration at or above the county level shall order correction and issue a warning; if correction is refused, a fine of not less than RMB 5,000 but not more than RMB 10,000 shall be imposed:
　　

(1) Where an enterprise engaged in the online sale of medical devices fails to display its Medical Device Production and Operation License or filing certificate, and its Medical Device Registration Certificate or filing certificate as required by these Measures;
　　

(2) Where a third-party platform provider for online medical device transactions fails to display the filing certificate number of the third-party platform for online medical device transactions as required by these Measures.

Article 41Where any of the following circumstances occurs, the local food and drug administration at or above the county level shall order corrections and issue a warning; if corrections are refused, a fine of not less than RMB 5,000 but not more than RMB 20,000 shall be imposed:
　　

(1) Where the filing information of an enterprise engaged in online sales of medical devices has changed, but the change has not been made in accordance with regulations;
　　

(2) Enterprises engaged in the online sale of medical devices fail to establish and implement quality management systems in accordance with regulations;
　　

(3) Where the third-party platform provider for online medical device trading services fails to handle changes in accordance with regulations when there are changes in the filing matters;
　　

(4) Where a third-party platform provider for online trading of medical devices fails to establish a quality and safety management agency commensurate with its scale or to appoint quality and safety management personnel as required by regulations;
　　

(5) Where a third-party platform provider for online medical device transactions fails to establish and implement a quality management system as required by regulations.

Article 42Where a third-party platform provider for online trading of medical devices fails to file the record in accordance with these Measures, the provincial-level food and drug administration shall order it to make corrections within a specified time limit; if it refuses to make such corrections, the matter shall be announced to the public, and a fine of not more than RMB 30,000 shall be imposed.

Article 43Where any of the following circumstances occurs, the local food and drug administration at or above the county level shall order correction and issue a warning; if correction is refused, a fine of not less than RMB 10,000 but not more than RMB 30,000 shall be imposed:
　　

(1) Where the conditions of enterprises engaged in online sales of medical devices or third-party platforms for online transaction services of medical devices change, and no longer meet the regulatory requirements;
　　

(2) Enterprises engaged in the online sales of medical devices and third-party platform providers for online medical device transactions that fail to cooperate with the supervision and inspection conducted by the food and drug administration departments, or that refuse, conceal, or fail to provide relevant materials and data truthfully.

Article 44Where any of the following circumstances occurs, the local food and drug administration at or above the county level shall order corrections and impose a fine of not less than RMB 10,000 but not more than RMB 30,000:
　　

(1) Enterprises engaged in online sales of medical devices selling beyond their approved business scope;
　　

(2) Medical device wholesalers selling to unlicensed distributors or user institutions.
　　

Where a medical device retail enterprise sells medical devices not intended for self-use by consumers to individual consumers, it shall be penalized in accordance with the provisions of Item 1 of the preceding paragraph.

Article 45Enterprises engaged in the online sale of medical devices that fail to transport or store such devices in accordance with the requirements specified in the instructions for use and labeling shall be penalized in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices.

Article 46Personnel of the food and drug regulatory authorities responsible for supervising the online sales of medical devices who fail to perform their duties, abuse their power, neglect their duties, or engage in malpractice for personal gain shall be held administratively liable in accordance with the law; if a crime is constituted, they shall be transferred to judicial organs for criminal liability.

Article 47Where medical devices or services provided by a third-party platform operator for online medical device transactions cause personal injury or property damage to others, the operator shall bear civil liability in accordance with relevant laws and regulations.

Chapter VI Supplementary Provisions

Article 48The format of the Record-Filing Certificate for Third-Party Platforms Providing Online Transaction Services for Medical Devices shall be uniformly formulated by the China Food and Drug Administration.
　　

The filing certificate for third-party platforms providing online transaction services for medical devices shall be printed by the provincial-level food and drug administration departments.
　　

The format of the filing certificate number for third-party platforms providing online trading services for medical devices is: (X) Wang Xie Ping Tai Bei Zi [XXXX] No. XXXXX. Wherein:
　　

The first "X" represents the abbreviation of the province, autonomous region, or municipality directly under the Central Government where the filing authority is located;
　　

The second to fifth digits, represented by X, denote the 4-digit year of filing;
　　

The 6th to 10th digits "X" represent a 5-digit filing serial number.

Article 49Online information services for medical devices shall be administered in accordance with the Measures for the Administration of Internet Drug Information Services.

Article 50These Measures shall come into force as of March 1, 2018.