Rfi for Vigilance Registration System in Transplantation Medicine None Tender, Switzerland - 97331370

Procurement Summary

Country : Switzerland

Summary : Rfi for Vigilance Registration System in Transplantation Medicine None

Deadline : 07 Mar 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 97331370

Document Ref. No. : 1398595

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

The parliament passed a change to the Transplantation Act on September 29, 2023. With the changes, patient safety in transplantation medicine with a comprehensive vigilance system can be further increased. Such vigilance systems have already been established in various medical areas, for example for medicines and medical devices. Today, the quality and safety of the transplants in Switzerland are still at a high level. There are strict requirements and all steps from the donation to the transplantation of organs, tissues or blood stem cells must be documented. So far, however, a reporting obligation for serious incidents and serious undesirable reactions has been missing. This reporting obligation is to be introduced. Anyone who has knowledge of a serious incident or a serious undesirable reaction must report this after the new regulation of the responsible vigilance body came into force. For this purpose, a new electronic system, the vigilance registration system (VMS) is planned, in which the reports are recorded and processed centrally. The VMS also serves to implement measures and recommendations and should ...
Demand/award office: Federal Office for Health Bag Procurement Center/Organizer: None, Contact, E-Mail Procurement.wto@bbl.admin.ch, switzerland
Publish Date: 21.02.2024
Procurement object
2.1 Project title of procurement: RFI for Vigilance registration system in transplantation medicine
2.3 Community vocabulary:
2.4 Subject and scope of the order: Parliament passed a change to the Transplantation Act on September 29, 2023. With the changes, patient safety in transplantation medicine with a comprehensive vigilance system can be further increased. Such vigilance systems have already been established in various medical areas, for example for medicines and medical devices. Today, the quality and safety of the transplants in Switzerland are still at a high level. There are strict requirements and all steps from the donation to the transplantation of organs, tissues or blood stem cells must be documented. So far, however, a reporting obligation for serious incidents and serious undesirable reactions has been missing. This reporting obligation is to be introduced. Anyone who has knowledge of a serious incident or a serious undesirable reaction must report this after the new regulation of the responsible vigilance body came into force. For this purpose, a new electronic system, the vigilance registration system (VMS) is planned, in which the reports are recorded and processed centrally ......

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