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The General Administration held a press conference on the Measures for the Supervision and Administration of Online Sales of Medical Devices

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  • Time of issue:2018-01-11
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(Summary description)On January 10,the State Food and Drug Administration held a press conference.The relevant person in charge of the Medical Device Supervision Department of the State Administration of Medical Device Supervision announced the latest"Measures for the Supervision and Administration of Medical Device Online Sales"(General Administration Order No.38,hereinafter referred to as the"Measures")Interpretation and analysis of the main content of the medical device network operation supervision situation.

The General Administration held a press conference on the Measures for the Supervision and Administration of Online Sales of Medical Devices

(Summary description)On January 10,the State Food and Drug Administration held a press conference.The relevant person in charge of the Medical Device Supervision Department of the State Administration of Medical Device Supervision announced the latest"Measures for the Supervision and Administration of Medical Device Online Sales"(General Administration Order No.38,hereinafter referred to as the"Measures")Interpretation and analysis of the main content of the medical device network operation supervision situation.

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2018-01-11
  • Views:0
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  On January 10,the State Food and Drug Administration held a press conference.The relevant person in charge of the Medical Device Supervision Department of the State Administration of Medical Device Supervision announced the latest"Measures for the Supervision and Administration of Medical Device Online Sales"(General Administration Order No.38,hereinafter referred to as the"Measures")Interpretation and analysis of the main content of the medical device network operation supervision situation.


  The relevant person in charge introduced that with the rapid development of online medical device sales,the use of the Internet to illegally sell unregistered medical devices,false exaggerated publicity,and deceive consumers continue to arise.For example,illegally selling unregistered medical device products,publishing illegal and illegal information on online e-commerce platforms,direct-sales websites or mobile clients,etc.,bring potential risks to the safety of the people's use of equipment.At the same time,the virtual nature,cross-regional,hidden,and easily transferred characteristics of network operations have also led to problems such as unclear supervisory jurisdiction responsibilities,lagging methods,difficulty in investigation and evidence collection,and lack of basis for law enforcement.Therefore,it is of great significance to improve relevant laws and regulations on online sales of medical devices,and to further clarify the main responsibility and supervision responsibility of online sales from the system level.


  According to the“Cyber​​Security Law”,“Regulations on the Supervision and Administration of Medical Devices”(hereinafter referred to as the“Regulations”),“Internet Information Service Management Measures”and other laws and regulations,the General Administration combined with the“Regarding Deepening the Reform of the Review and Approval System and Encourage Drugs and Medical Devices”Innovative Opinions,and the reality of the supervision of online sales of medical devices,formulated the Measures.There are 50 articles in the"Measures",including legislative purposes,scope of application,obligations of companies engaged in online medical device sales and third-party platform providers of medical device online transaction services,supervision and management,and legal responsibilities.


  The relevant person in charge emphasized that the“Measures”clarified that the supervision of online sales of medical devices follows the principle of“online and offline consistency”.Medical device manufacturers and marketing license holders engaged in online sales should comply with the“Regulations”and“Regulations”.The requirements of the Measures:third-party platform providers of online transaction services should review the operating qualifications of enterprises registered on their platforms.


  The Measures also require online sales companies and online transaction service third-party platform providers to file with the municipal and provincial bureaus respectively,and further refine the obligations of online sales companies and online transaction service third-party platform providers,and stipulate that online sales companies The quality and safety of medical devices should be guaranteed;third-party platform providers should establish management systems for verification and registration,quality and safety monitoring,etc.of enterprises on the platform,and immediately stop and report online transaction services for illegal operators and illegal products;online sales companies and third-party platforms provide The author shall guarantee the authenticity,completeness and traceability of sales transaction data and materials.


  Regarding the network business scope of enterprises engaged in the online sales of medical devices,the"Measures"clarify that"it shall not exceed the scope of its production and operation license or filing."A medical device wholesale enterprise engaged in online sales of medical devices shall sell to qualified medical device operating enterprises or users.Medical device retail enterprises engaged in online sales of medical devices shall sell to consumers.Medical devices sold to consumers should be personally useable by consumers,and their instructions should comply with the relevant regulations on medical device instructions and label management,with special instructions for safe use.


  The“Measures”clarified that the General Administration shall organize the establishment of a national medical device online transaction monitoring platform to carry out national medical device online sales and online transaction monitoring and disposal.According to the relevant person in charge,the General Administration has begun to organize the establishment of a national medical device network transaction monitoring platform in 2016.The monitoring platform construction project is divided into three phases.Up to now,the first phase of the monitoring platform has been completed.During the trial operation of the monitoring platform,Large-scale e-commerce platforms and information service websites with Internet drug information service qualification certificates conducted data collection and monitoring,and the monitored information on violations of laws and regulations was promptly transferred to relevant provincial(regional,municipal)food and drug supervision and administration departments to supervise online medical device sales Management played an active role.


  The quality and safety of medical devices sold online is an issue of great concern to the public.According to the relevant person in charge,the"Measures"strengthened risk control.During the inspection,the food and drug regulatory authorities found that enterprises engaged in online sales of medical devices or third-party platform providers had not established and implemented relevant quality management systems in accordance with regulations,and there were medical device quality safety If there are hidden dangers,the supervisory authority may order it to suspend online sales or suspend the provision of related online transaction services.Where there are quality and safety issues that may cause medical device quality and safety risks,the provincial and municipal bureaus may interview the legal representative or main person in charge of the online sales enterprise or third-party platform provider,and suspend the implementation of the refusal For online sales,suspension of the provision of related online transaction services,or online sales companies and third-party platform providers that refuse to rectify as required after being interviewed,the food and drug regulatory authority may include their legal representatives or principals as untrustworthy enterprises and untrustworthy companies The list of personnel shall be disclosed to the public.


  In addition,the"Measures"also clarified that medical device network information services shall be implemented in accordance with the"Administrative Measures for Internet Drug Information Services."The relevant person in charge emphasized that enterprises engaged in online sales of medical devices through self-built websites and third-party platform providers of medical device transaction services should obtain the"Internet Drug Information Service Qualification Certificate"in accordance with the"Internet Drug Information Service Management Measures".

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