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

 2018-05-12  45


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

  • Document NumberOrder No. 38 of the China Food and Drug Administration
  • Area of Law Health and Sanitation Post and Telecommunications
  • Level of Authority Departmental Rules
  • Date issued12-20-2017
  • Effective Date03-01-2018
  • Status Effective
  • Issuing Authority All Administrations



Order of the China Food and Drug Administration
(No. 38)
The Measures for the Supervision and Administration of Online Sale of Medical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017, are hereby issued and shall come into force on March 1, 2018.
Director: Bi Jingquan
December 20, 2017
Measures for the Supervision and Administration of Online Sale of Medical Devices
Chapter I General Provisions
Article 1 For the purposes of strengthening the supervision and administration of online sale of medical devices and online trading services for medical devices, and protecting the security of the use of devices by the public, these Measures are developed according to the Cybersecurity Law of the People's Republic of China, the Regulation on the Supervision and Administration of Medical Devices, the Measures for the Administration of Internet Information Services and other laws and regulations.
Article 2 These Measures shall apply to the online sale of medical devices, the provision of online trading services for medical devices and the supervision and administration thereof within the territory of the People's Republic of China.
Article 3 The China Food and Drug Administration (“CFDA”) shall be responsible for directing the supervision and administration of online sale of medical devices and online trading services for medical devices across the country, and organize the monitoring of online sale of and online trading services for medical devices.
The provincial food and drug administrative departments shall be responsible for the supervision and administration of online trading services for medical devices.
The local food and drug administrative departments at or above the county level shall be responsible for the supervision and administration of online sale of medical devices within their respective administrative regions.
Article 4 Enterprises engaging in online sale of medical devices or providers of third-party platforms for online trading services for medical devices shall comply with the laws, regulations, rules and specifications on medical devices, establish and improve the management system, conduct business with good faith according to the law, and guarantee the quality and safety of medical devices.
“Enterprises engaging in online sale of medical devices” means the holders of the marketing licensing of medical devices that sell medical devices online (i.e., registrants or recordation handling parties of medical devices, hereinafter referred to as “holders”) and enterprises engaging in production and business operation of medical devices.
“Providers of third-party platforms for online trading services for medical devices” means enterprises that only provide webpage space, virtual trading venues, trading rules, match-making, electronic orders and other trading services in the online trading of medical devices, which are available for both or all trading parties to independently carry out trading activities, and that do not directly participate in the sale of medical devices.
Article 5 Enterprises engaging in online sale of medical devices and providers of third-party platforms for online trading services for medical devices shall take technical measures to guarantee the authenticity, integrity and traceability of online sales data and materials of medical devices.
Article 6 Enterprises engaging in online sale of medical devices and providers of third-party platforms for online trading services for medical devices shall actively cooperate with the food and drug administrative departments to conduct network monitoring, sampling inspection, on-site inspection and other supervision and administration, and store data, provide information inquiry, data extraction and other relevant support according to the requirements of the food and drug administrative departments.
Chapter II Online Sale of Medical Devices
Article 7 An enterprise engaging in online sale of medical devices shall be an enterprise engaging in production and business operation of medical devices that has obtained the production permit and business permit for medical devices or has undergone the formalities of recordation according to the law, except under the circumstances of exemption from obtaining permit or undergo the formalities of recordation as prescribed in laws and regulations.
A holder selling medical devices online and a medical device manufacturer entrusted by the holder to sell medical devices manufactured upon commission online is not required to obtain any business permit or undergo formalities of recordation, but the sales conditions shall satisfy the requirements of the Regulation on the Supervision and Administration of Medical Devices and these Measures.
A holder entrusting online sale of medical devices shall assess and confirm the legal qualification, sales conditions, technical level, and quality management capacity of the entrusted party, direct and supervise the online sale process and quality control, and be responsible for the quality of the medical devices sold online.
Article 8 An enterprise engaging in online sale of medical devices shall enter the information sheet of online sale of medical devices, and undergo the recordation formalities with the food and drug administrative department at the districted city level in the place where it is located in advance for the enterprise name, legal representative or primary person in charge, website name, name of the online Client app, website domain name, website IP address, business permit for telecommunications services or recordation number of non-operational Internet information services, serial number of the license for the production and operation of medical devices or recordation certificate, and other information. Where the relevant information changes, the formalities of modification recordation shall be undergone in a timely manner.
Article 9 An enterprise engaging in online sale of medical devices shall carry out online sale of medical devices through its own website or a third-party platform for online trading services for medical devices.
An enterprise engaging in online sale of medical devices through its own website shall obtain the Qualification Certificate for Internet Drug Information Services in accordance with the law, and have office premises, data backup, failure recovery and other technical conditions commensurate with its size.
Article 10 An enterprise engaging in online sale of medical devices shall display its license for the production and operation of medical devices or recordation certificate in a conspicuous position on its homepage, and display the medical device registration certificate or recordation certificate of the product on the product page. The relevant information displayed shall be clear and easy to identify. The serial numbers of the license for the production and operation of medical devices or recordation certificate, and the medical device registration certificate or recordation certificate shall be displayed in the form of text. In the event of any change in the relevant information, the displayed contents shall be updated in a timely manner.
Article 11 The name, model, specifications, structure and composition, scope of application, serial number of the medical device registration certificate or recordation certificate, information on the registrant or recordation handling party, serial number of the production permit or recordation certificate, serial number of the technical requirements for the product, contraindications, and other information on a medical device issued online by an enterprise engaging in online sale of medical devices shall be consistent with the relevant contents registered or recorded.
Article 12 An enterprise engaging in online sale of medical devices shall record the information on sale of medical devices and keep it for a period of 2 years after the validity period of medical devices; the sales information on medical devices without validity period shall be kept for a period of not less than 5 years; and the sales information on implantable medical devices shall be kept permanently. Relevant records shall be authentic, complete and retrospective.
Article 13 An enterprise engaging in online sale of medical devices shall not carry out business activities beyond the business scope as specified in the license for production and operation or recorded.
A medical device wholesale enterprise engaging in online sale of medical devices shall sell medical devices to qualified medical device business enterprises or using entities.
A medical device retail enterprise engaging in online sale of medical devices shall sell medical devices to consumers. The medical devices sold to individual consumers shall be able to be used by consumers themselves, and the instructions thereof shall comply with the manuals of medical devices and relevant provisions on label management, and indicate the special instructions for the safe use.
Article 14 An enterprise engaging in online sale of medical devices shall store and transport medical devices according to the conditions as indicated in the labels and manuals of medical devices. An enterprise entrusting another entity to store or transport medical devices shall assess the capacity of the entrusted party for guaranteeing the quality of the medical devices to be stored and transported, specify the quality and safety liability during the storage and transportation process, and ensure the quality and safety during the process of storage and transportation.
Chapter III Online Trading Services for Medical Devices
Article 15 A provider of a third-party platform for online trading services for medical devices shall obtain the Qualification Certificate for Internet Drug Information Services in accordance with the law, have office premises, data backup, failure recovery and other technical conditions commensurate with its size, and set up a special medical device network quality safety management institution or employ medical device quality safety management personnel.
Article 16 A provider of a third-party platform for online trading services for medical devices shall undergo the recordation formalities with the provincial food and drug administrative department at the place where it is located, enter the recordation form of the third-party platform for online trading services for medical devices, and submit the following materials:
(1) the original and photocopy of the business license;
(2) the originals and photocopies of the identifications of the legal representative or primary person in charge, and medical device quality and safety manager;
(3) the explanations for the organizational structure and setup of departments;
(4) the originals and photocopies of the geological location map and house property right certificate or leasing agreement of the office place (with the house property right certificate annexed);
(5) the original and photocopy of the telecommunication business permit or the recordation explanation for the non-operational Internet information services;
(6) the original and photocopy of the Qualification Certificate for Internet Drug Information Services;
(7) the catalogue of the rules on management of the quality of online trading services for medical devices and other documents;
(8) the introduction to and functional specification for the basic information on the website or online Client app; and
(9) other relevant certification materials.
Article 17 The provincial food and drug administrative department shall check the integrity of the materials submitted by an enterprise on the spot, undergo the recordation formalities for an enterprise in compliance with the provisions, and grant a recordation certificate for a third-party platform for online trading services for medical devices there to; and notify an enterprise whose materials submitted are incomplete or that does not fall under the statutory circumstances of the materials to be supplemented at a time.
The provincial food and drug administrative department shall disclose the relevant recordation information to the public within 7 working days after the recordation formalities are undergone. The recordation information includes the enterprise name, legal representative or primary person in charge, website name, name of the online Client app, website domain name, website IP address, business permit for telecommunications services or recordation number of non-operational Internet information services, and serial number of the recordation certificate for the third-party platform for online information services for medical devices, among others.
The provincial food and drug administrative department shall conduct on-site inspection of a third-party platform for online trading services for medical devices within 3 months after a provider of a third-party platform for online trading services for medical devices undergoes the recordation formalities.
Article 18 In the event of change in the name of a provider of a third-party platform for online trading services for medical devices, legal representative or primary person in charge, website name, name of the online Client app, website domain name, website IP address, business permit for telecommunications services or recordation number of non-operational Internet information services and other recordation information, the formalities of modification recordation shall be undergone in a timely manner.
Article 19 A provider of a third-party platform for online trading services for medical devices shall indicate the serial number of the recordation certificate of a third-party platform for online trading services for medical devices in a conspicuous position at the homepage of its website.
Article 20 A provider of a third-party platform for online trading services for medical devices shall establish the management systems of verification and registration of enterprises registered on the platform, quality and safety monitoring, guarantee of trading security, prohibition and reporting of illegal acts of online sale, ceasing services of platforms with severe illegal acts, handling of safety complaints and tip-offs, protection of consumers' rights and interests and announcement of quality and safety information, among others.
Article 21 A provider of a third-party platform for online trading services for medical devices shall verify the licenses for the production and operation of medical devices or recordation certificates, registration certificates or recordation certificates of medical devices, business licenses of enterprises and other materials submitted by enterprises applying for registration on the platform, establish files and update them in a timely manner, and ensure that the permits or recordation information on production and operation premises indicated in enterprises' permits or recordation certificates are authentic.
A provider of a third-party platform for online trading services for medical devices shall enter into a registration agreement with an enterprise registered on the platform, and specify the obligations of the two parties, default disposal measures and other relevant contents in the agreement.
Article 22 A provider of a third-party platform for online trading services for medical devices shall record the information on the trading of medical devices carried out on the platform and keep it for a period of 2 years after the validity period of medical devices; the trading information on medical devices without validity period shall be kept for a period of not less than 5 years; and the trading information on implantable medical devices shall be kept permanently. Relevant records shall be authentic, complete and retrospective.
Article 23 A provider of a third-party platform for online trading services for medical devices shall monitor the sale of medical devices and the information on the platform, and shall, when discovering that an enterprise registered on a third-party platform for online trading services carries out business activities beyond the business scope, issues false information, conducts exaggerated publicity and has other acts in violation of laws and regulations, is unavailable, or has other serious safety loopholes, immediately cease the online trading services therefor, keep relevant records, and report to the provincial food and drug administrative department in the place where it is located.
When finding that an enterprise registered on a third-party platform for online trading services is ordered by the food and drug administrative department to cease production and business, and is subject to revocation of permits and other penalties, or the sale of products traded on the platform is suspended or ceased by the food and drug administrative department, a provider shall immediately cease the provision of relevant online trading services.
Article 24 A provider of a third-party platform for online trading services for medical devices shall, in a conspicuous position at its website, issue potential product quality safety risks and other information in a timely manner.
Chapter IV Supervision and Inspection
Article 25 The food and drug administrative department shall, in accordance with the provisions of laws, regulations and rules, conduct supervision and inspection and sampling inspection of the enterprises engaging in online sale of medical devices and third-party platforms for online trading services for medical devices according to the functions.
Article 26 The investigation and punishment of the enterprises engaging in online sale of medical devices that have acts in violation of the law shall be governed by the local food and drug administrative department at or above the county level in the place where it is located.
Where an enterprise engages in online sale of medical devices without obtaining a permit or undergoing recordation formalities and the location of the enterprise selling products illegally is able to be determined, the investigation and punishment shall be governed by the local food and drug administrative department at or above the county level in the enterprise selling products illegally where it is located; where the location of the enterprise selling products illegally is unable to be determined, the investigation and punishment shall be governed by the local food and drug administrative department at or above the county level in the place where illegal sale is conducted or where the results of the illegal sale occur. Where products are sold on a third-party platform for online trading services for medical devices, the investigation and punishment shall be governed by the provincial food and drug administrative department in the place where the provider of the third-party platform for online trading services for medical devices is located; and where the region with jurisdiction is able to be determined upon investigation, the case shall be transferred to the food and drug administrative department with jurisdiction in a timely manner.
The investigation and punishment of the illegal acts of a provider of a third-party platform for online trading services for medical devices shall be governed by the provincial food and drug administrative department in the place where it is located.
Where a medical device sold online causes a major quality accident or any other serious hazardous consequences, the investigation and punishment shall be governed by the provincial food and drug administrative department in the place where the illegal enterprise is located, where illegal sale is conducted or where the results of the illegal sale occur; and where the consequences are particularly serious, the provincial food and drug administrative department may submit a request to the CFDA for coordination or organization of direct investigation and punishment.
The provincial food and drug administrative department shall notify the competent communications department at the same level of the website that illegally conducts online sale of medical devices.
Article 27 The CFDA shall organize the establishment of a national monitoring platform for online trading of medical devices, monitor and handle online sale and online trading of medical devices across the country, and report the monitoring situation to the provincial food and drug administrative departments on a regular basis. The information on suspected violations of laws and regulations found in monitoring shall be transferred to the relevant provincial food and drug administrative department in a timely manner. The provincial food and drug administrative department shall organize the handling in a timely manner.
Article 28 The monitoring platforms for online sale of medical devices independently established by the provincial food and drug administrative department shall realize data connection with the national monitoring platform for online trading of medical devices.
Article 29 When conducting routine supervision and administration of online sale of medical devices or investigating and punishing enterprises conducting online sale of medical devices that are suspected of violating laws and regulations, the food and drug administrative department shall have the right to take the following measures:
(1) entering the medical device business premises, office premises and locations of servers of the enterprises to conduct on-site inspection;
(2) conducting sampling inspections of the medical devices to be sold online;
(3) inquiring about relevant persons, and investigating the relevant information on enterprises' online sales of medical devices;
(4) consulting and copying the transaction data, contracts, commercial papers, account books and other relevant materials of the enterprise;
(5) obtaining the technical monitoring and recording materials on online sale;
(6) seizing and detaining data storage media, among others according to the law; and
(7) other measures that may be taken as prescribed by laws and regulations.
Article 30 Sampling inspection of medical devices to be sold online shall be conducted according to the relevant administrative provisions on the quality supervision and sampling inspection of medical devices.
If the inspection results do not meet the quality and safety standards for medical devices, the food and drug administrative department shall, upon receipt of an inspection report, conduct supervision and inspection of the relevant production and operation enterprise in a timely manner, take control measures, issue quality announcement in a timely manner, and investigate and punish violators according to the law.
Article 31 The food and drug administrative department may regard the technical monitoring records or information traceability materials on online sale of medical devices as the basis for determining the illegal facts in online sale of medical devices.
Article 32 Where the actual situation of an enterprise engaging in online sale of medical devices is inconsistent with the recordation information and the enterprise is unable to be contacted, upon announcement by the food and drug administrative department at the districted city level in the place where it is located, its Medical Device Operation Permit shall be revoked according to the law or a mark shall be indicated in the recordation information on operation of Class II medical devices and be announced to the public. The provincial food and drug administrative department shall notify the competent communications department at the same level of the relevant website.
Where the actual situation of a provider of a third-party platform for online trading services for medical devices is inconsistent with the recordation information and the provider is unable to be contacted, upon announcement by the provincial food and drug administrative department in the place where the original recordation formalities are undergone, a mark shall be indicated in the recordation information and be announced to the public; and where false materials are provided in recordation, the provincial food and drug administrative department shall announce the recordation entity to the public. The provincial food and drug administrative department shall notify the competent communications department at the same level of its website.
Article 33 Where a food and drug administrative department finds in the inspection that an enterprise engaging in online sale of medical devices or a third-party platform for online trading services for medical devices fails to establish and implement a relevant quality management system as required and has potential quality and safety risks in medical devices, the food and drug administrative department may order it to suspend online sale or suspend the provision of relevant online trading services.
To resume online sale or provision of relevant online trading services, an enterprise engaging in online sale of medical devices or a provider of a third-party platform for online trading services for medical devices shall file an application with the food and drug administrative department that originally makes a decision of handling, and may only resume online sale or provision of relevant online trading services after passing the examination of the food and drug administrative department.
Article 34 Where an enterprise engaging in online sale of medical devices or a provider of a third-party platform for online trading services for medical devices falls under one of the following circumstances, the food and drug administrative department may, according to the functions, hold an interview with its legal representative or primary person in charge:
(1) A quality and safety problem of medical devices occurs and may lead to quality and safety risks in medical devices.
(2) It fails to appropriately handle the quality problems of medical devices complained and tipped off, and may have potential quality and safety risks in medical devices.
(3) It fails to take effective measures in a timely manner to check and eliminate the potential quality and safety risks in medical devices and fails to fulfill the responsibilities for the quality and safety of medical devices.
(4) Other circumstances under which an interview is necessary to be held.
An interview shall not affect the administrative punishment imposed by the food and drug administrative department according to the law, and the interview and follow-up punishment may be disclosed to the public.
Where an enterprise with which an interview is held fails to implement rectification as required without any justifiable reason, the provincial food and drug administrative department or the food and drug administrative department at the districted city level in the place where it is located shall, according to the functions, increase the frequency and times of supervision and inspection.
Article 35 Under one of the following circumstances, the food and drug administrative departments may include the enterprises engaging in online sale of medical devices, providers of third-party platforms for online trading services for medical devices and their legal representatives or primary persons in charge in the list of faith-losing enterprises and personnel, and announce them to the public:
(1) An enterprise refuses to implement the decision of suspending online sale or provision of relevant online trading services.
(2) An enterprise refuses to make rectification after an interview is held.
Article 36 The local food and drug administrative departments at or above the county level shall summarize and analyze the information on supervision and administration of online sale of medical devices within their respective administrative regions on a regular basis, report to the food and drug administrative departments at next higher levels, and disclose them to the public according to the law.
The provincial food and drug administrative departments shall summarize and analyze the information on supervision and administration of the third-party platforms for online sale of medical devices and online trading services on an annual basis, report to the CFDA, and disclose them to the public in accordance with the law.
Chapter V Legal Liability
Article 37 Where there have been provisions prescribed in laws and regulations on sale or provision of trading services by enterprises engaging in online sale of medical devices and providers of third-party platforms for online trading services for medical devices in violation of the relevant provisions of laws and regulations, such provisions shall apply. Where a crime is constituted, the violator shall be transferred to the public security organ.
Article 38 Those who sell Class III medical devices online without a business permit for medical devices in violation of the provisions of these Measures shall be given penalties according to the provisions of Article 63 of the Regulation on the Supervision and Administration of Medical Devices; and those who sell Class II medical devices online without a recordation certificate for operation of Class II medical devices shall be given penalties according to the provisions of Article 65 of the Regulation on the Supervision and Administration of Medical Devices.
Article 39 An enterprise engaging in online sale of medical devices that fails to undergo the recordation formalities according to the provisions of these Measures shall be ordered to take corrective action within a prescribed time limit and be given a warning by the local food and drug administrative department at or above the county level; and an enterprise that refuses to take corrective action shall be announced to the public and be fined not more than 10,000 yuan.
Article 40 An entity falling under one of the following circumstances shall be ordered to make corrective action and be given a warning by the local food and drug administrative department at or above the county level; and an enterprise that refuses to take corrective action shall be fined not less than 5,000 yuan nor more than 10,000 yuan:
(1) An enterprise engaging in online sale of medical devices fails to display the license for the production and operation of medical devices or recordation certificate, medical device registration certificate or recordation certificate according to the requirements of these Measures.
(2) A provider of a third-party platform for online trading services for medical devices fails to display the serial number of the recordation certificate of the third-party platform for online trading services for medical devices according to the requirements of these Measures.
Article 41 An entity falling under one of the following circumstances shall be ordered to make corrective action and be given a warning by the local food and drug administrative department at or above the county level; and an enterprise that refuses to take corrective action shall be fined not less than 5,000 yuan nor more than 20,000 yuan:
(1) An enterprise engaging in online sale of medical devices fails to conduct modification as required in the event of change in its recordation information.
(2) An enterprise engaging in online sale of medical devices fails to establish and implement the quality management system as required.
(3) A provider of a third-party platform for online trading services for medical devices fails to conduct modification as required in the event of change in its recordation matter.
(4) A provider of a third-party platform for online trading services for medical devices fails to form a quality and safety management institution or appoint quality and safety management personnel commensurate with its size as required.
(5) A provider of a third-party platform for online trading services for medical devices fails to establish and implement the quality management system as required.
Article 42 A provider of a third-party platform for online trading services for medical devices that fails to undergo the recordation formalities according to the provisions of these Measures shall be ordered to take corrective action within a prescribed time limit by the provincial food and drug administrative department; and an enterprise that refuses to take corrective action shall be announced to the public and be fined not more than 30,000 yuan.
Article 43 An entity falling under one of the following circumstances shall be ordered to make corrective action and be given a warning by the local food and drug administrative department at or above the county level; and an enterprise that refuses to take corrective action shall be fined not less than 10,000 yuan nor more than 30,000 yuan:
(1) An enterprise engaging in online sale of medical devices or a third-party platform for online trading services for medical devices changes its conditions and no longer satisfies the requirements prescribed.
(2) An enterprise engaging in online sale of medical devices or a provider of a third-party platform for online trading services for medical devices does not cooperate with the supervision and inspection by the food and drug administrative department, or refuses, conceals or untruthfully provides relevant materials and data.
Article 44 An entity falling under one of the following circumstances shall be ordered to make corrective action by the local food and drug administrative department at or above the county level and be fined not less than 10,000 yuan nor more than 30,000 yuan:
(1) An enterprise engaging in online sale of medical devices sells medical devices beyond its business scope.
(2) A medical device wholesale enterprise sells products to an unqualified business enterprise or using entity.
A medical device retail enterprise that sells medical devices not to be used by consumers to individual consumers shall be given penalties in accordance with the provisions of item (1) of the preceding paragraph.
Article 45 An enterprise engaging in online sale of medical devices that fails to transport or store medical devices according to the manuals of medical devices and requirements for labels shall be fined according to the provisions of Article 67 of the Regulation on the Supervision and Administration of Medical Devices.
Article 46 A staff member of the food and drug administrative department in charge of the supervision of the online sale of medical devices that does not fulfill the functions or abuses powers, neglects duties, practices favoritism or makes falsification shall be held administratively liable according to the law; and be transferred to the judicial organ to be subject to criminal liability, where a crime is constituted.
Article 47 A provider of a third-party platform for online trading services for medical devices providing medical devices or services that have caused personal or property losses to others shall assume civil liability according to the provisions of relevant laws and regulations.
Chapter VI Supplementary Provisions
Article 48 The format for the recordation certificates of third-party platforms for online trading services for medical devices shall be developed in a unified manner by the CFDA.
The recordation certificates for third-party platforms for online trading services for medical devices shall be printed by the provincial food and drug administrative department.
A recordation certificate for a third-party platform for online trading services for medical devices shall be numbered as follows: (X) Online Device Platform Recordation [XXXX] No. XXXXX, in which,
The first X stands for the abbreviation of the province, autonomous region or municipality directly under the Central Government at the place where the recordation department is located.
The second to fifth X stands for the four-digit year of recordation.
The sixth to tenth X stands for the five-digit serial number of recordation.
Article 49 The network information services for medical devices shall be governed by the Measures for the Administration of Internet Drug Information Services.
Article 50 These Measures shall come into force on March 1, 2018.