In order to strengthen the supervision of online sales of medical devices, thoroughly implement the "four strictest" requirements for drug safety, fully implement the "Measures for the Supervision and Administration of Medical Device Online Sales" and "Administrative Measures for Internet Drug Information Services", and further strengthen medical device online transaction services The management responsibility of the third-party platform (hereinafter referred to as the third-party platform) and the main responsibility of the medical device online sales enterprise (hereinafter referred to as the online sales enterprise), regulate the online marketing order of medical devices, severely punish all kinds of violations of laws and regulations, and ensure the safety of the masses in the use of equipment. To save the actual situation, formulate this plan.

1. Guiding ideology and work objectives

(1) Guiding ideology

Guided by Xi Jinping’s thoughts on socialism with Chinese characteristics for a new era, implement the central government’s "four strictest" requirements for drug safety, adhere to the principles of "online" and "offline" linkage, information and product integration, and effectively strengthen the online sales of medical devices Supervise and manage, severely crack down on illegal and illegal behaviors in the online and offline sales of medical devices, continue to purify the online sales environment of medical devices, and ensure the safety of the public in using devices.

(two) work objectives

1. Strengthen the implementation of third-party platform management responsibilities

The third-party platform fully implements the management responsibilities of settled enterprises, such as verification and registration, quality and safety monitoring, product quality and safety hidden danger information release, suppression of illegal online sales, suspension of platform services for serious violations, and related reports.

2. Strengthen the implementation of the main responsibility of medical device online sales enterprises

Online sales companies ensure that the information is true, accurate, complete, and traceable, and that transactions comply with legal requirements.

3. Strengthen the implementation of the territorial supervision responsibility of the drug supervision department

The relevant departments (units) of the Provincial Bureau and the supervisory departments of each city (prefecture) shall comprehensively strengthen the supervision of third-party platforms and online sales companies in the administrative area in accordance with their duties, and supervise the implementation of management responsibilities of third-party platforms and the implementation of main responsibilities of online sales companies. Strictly investigate and deal with violations of laws and regulations.

4. Strengthen the monitoring of online transactions of medical devices and the handling of clues.

The relevant departments (units) of the provincial bureau promptly push the relevant clues of online sales enterprises on the national medical device online transaction monitoring platform to the municipal (prefecture) regulatory authorities, and each city (prefecture) regulatory agency shall promptly report and investigate on the national medical device online transaction monitoring platform And disposal.

5. Strengthen the investigation and punishment of violations of laws and regulations

All relevant departments (units) of the Provincial Bureau and the supervisory departments of each city (state) shall, in accordance with the "four strictest" requirements, promptly investigate and deal with various violations of laws and regulations in accordance with the law, and further enhance the authority and deterrence of law enforcement.

2. Key tasks

(1) Check the full performance of management responsibilities by third-party platforms

All relevant departments (units) of the Provincial Bureau strengthen the supervision and inspection of third-party platforms in the administrative area, and focus on checking the performance of the following management responsibilities by third-party platforms.

1. Whether the third-party platform fulfills various statutory obligations in accordance with the Measures for the Supervision and Administration of Online Sales of Medical Devices;

2. After the third-party platform monitors and discovers the illegal behavior of the settled company, whether it reports to the local drug regulatory authority in a timely manner;

3. Whether the third-party platform cooperates with the drug regulatory authority to perform relevant investigation and verification obligations;

4. Whether the third-party platform promptly disposes of the illegally settled enterprises and product information in accordance with the requirements of the regulatory authorities.

(2) Check the full performance of the main responsibility of online sales companies

The municipal (prefecture) supervisory department strengthens the supervision and inspection of network sales enterprises in the administrative area, and focuses on the inspection of the performance of the following main responsibilities of the network sales enterprises.

1. Whether the information released by online sales companies through the Internet is true, accurate, complete, and traceable, and whether there are false and exaggerated publicity;

2. Whether the products and business behaviors sold by online sales companies meet the relevant requirements of the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Operation", "Measures for the Supervision and Administration of Online Medical Device Sales", and "Administrative Measures on Internet Drug Information Services".

(3) Strengthen the investigation and punishment of violations of laws and regulations by regulatory agencies at all levels

The relevant departments (units) of the provincial bureau and the supervisory departments of each city (prefecture) shall promptly investigate and deal with the illegal clues found in network monitoring, public opinion monitoring, complaints and reporting, and focus on the investigation and punishment of third-party platforms and online sales companies. Irregularities.

1. The third-party platform failed to fulfill its statutory obligations, failed to verify the settled company, failed to monitor the medical device sales behavior and information on the platform, and found illegal activities and failed to stop online transaction services and reporting illegal activities;

2. Internet sales companies sell unregistered or filed medical device products, publish false medical device product information and other violations of laws and regulations;

3. Third-party platforms and online sales companies do not cooperate with the supervision and inspection of the drug regulatory department, and refuse, conceal, or provide untruthful information and other illegal activities.

(4) Strengthen the monitoring of online medical device transactions

The National Medical Device Network Transaction Monitoring Platform has carried out comprehensive monitoring of third-party platforms and online sales companies across the country, and opened up the medical device network monitoring function. The relevant departments (units) of the provincial bureau and the municipal (prefecture) regulatory authorities have made full use of the platform to carry out Medical device online transaction monitoring.

1. All relevant departments (units) of the provincial bureau make full use of the national medical device network transaction monitoring platform to timely transfer the national medical device network transaction monitoring platform and other relevant clues of online sales enterprises discovered by other provincial bureaus to the municipal (prefecture) regulatory authorities. COVID-19 prevention and control related new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, infrared thermometers, five types of medical equipment and contact lenses, blood glucose meters, condoms, therapeutic instruments, dental root canal nails, dental resin and other medical equipment are For key products, conduct comprehensive monitoring and clue handling on third-party platforms in the province.

2. Each city (prefecture) regulatory authority shall conduct comprehensive monitoring and clue handling of online sales companies within its jurisdiction, attach great importance to the problems reflected in information monitoring, and conduct investigations and verifications in the first time on the problems reflected in the information transmitted by the national and provincial bureaus Dispose of them in accordance with the law, and upload the disposal situation to the national medical device network transaction monitoring platform in a timely manner.

(5) Strengthen departmental collaboration and execution connection

The relevant departments (units) of the Provincial Bureau and the supervisory departments of each city (state) should strengthen inter-departmental coordinated supervision and jointly crack down on illegal activities of medical device online sales. For matters involving website closure or blocking, the network information and communications management departments shall be notified in a timely manner. For enterprises that cannot be contacted, they must promptly notify the market supervision department to be included in the abnormal list. Those suspected of crimes shall be transferred to the public security organs in a timely manner to jointly crack down on violations of laws and regulations.

Three, job requirements

(1) Improve political positions

The relevant departments (units) of the provincial bureau and the supervisory departments of each city (prefecture) should attach great importance to the "net cleaning" action, carefully formulate work plans, take effective measures, and effectively strengthen the supervision and inspection of third-party platforms and online sales companies in their administrative regions , Seriously investigate and deal with illegal acts.

(2) Strengthen demonstration and guidance

According to the requirements of the State Food and Drug Administration, Sichuan Province will select a number of cities from among the 21 municipal (prefecture) regulatory agencies to serve as contact points for regulatory work. All municipal (prefecture) regulatory agencies should focus on the construction of typical demonstrations and give full play to the leading role of demonstration units.

(3) Strengthen assessment and evaluation

The provincial bureau will timely supervise and inspect the implementation of the "cleaning network" action in each city (state), and include the implementation of local regulatory responsibilities, the disposal of network monitoring clues, and the investigation and punishment of violations of laws and regulations into the content of the year-end assessment.

(4) Strictly investigate violations

All municipal (prefecture) supervisory departments must conscientiously implement the "four most stringent" requirements, and intensify inspections of violations of laws and regulations. "Online" false information must not be "deleted" or "taken off the shelf". It is necessary to dig in and investigate thoroughly, and never tolerate it.

Each city (prefecture) supervisory authority shall summarize and analyze the work of the medical device "cleaning network" in 2020, sort out existing problems and put forward work recommendations, collect and sort out typical cases, and fill in the medical device "cleaning network" operation supervision and inspection form ( Attachment 1), Network Monitoring and Disposal Status Sheet (Annex 2), and submit work summary, action supervision and inspection status, network monitoring and disposal status and collected typical cases to the Provincial Bureau of Medical Device Supervision before November 15, 2020 Place. If there are major issues in the work, they must be reported in time.

Contact: Chen Sijia Tel: 028-86785825

Address: Medical Device Supervision and Administration Office, No. 98 Yusha Road, Qingyang District, Chengdu

Email: 1394725515@qq.com

Attachment:

1. Supervision and inspection status table of the medical device "cleaning network" action

2. Network monitoring and disposal status table

3. Typical case format template

Sichuan Drug Administration (2020) No. 71 (Annex)