Overview of Government Acquisition of Medical Devices

2025-01-07 104
(1) The usual methods for acquiring medical devices in China
Due to the variety of medical devices involved, strong professionalism, multiple regulations, and large quotation distances, the acquisition methods and procedures applicable to them are also different. At present, the primary methods for non-profit medical organizations in China to acquire medical devices include government centralized procurement, entrusted bidding companies for bidding, professional unified bidding, hospital independent bidding, and direct procurement. During this period, the regulations of the Chinese Government Acquisition Law stipulate that if state-owned medical organizations acquire medical equipment that falls within the government's centralized acquisition catalog or exceeds the prescribed limit, they must follow the government's acquisition method and be carried out in detail by the government's centralized acquisition organization.
(2) Several methods for government procurement of medical devices
The primary methods of government acquisition are disclosure bidding, invitation bidding, competitive negotiation, single source acquisition, inquiry, and other acquisition methods determined by the government acquisition supervision and management department of the State Council, and it is clearly stated that disclosure bidding is the primary method. There are regulations in various provinces and cities in China regarding the selection and review of acquisition methods.
(3) Medical Device Government Acquisition Procedure
At present, the fundamental procedure for government procurement of medical devices is that the acquirer first applies to the finance department, and after the finance department completes the project, entrusts the government procurement organization to act as the agent for bidding and procurement; The collective acquisition organization needs to prepare bidding and acquisition documents for the technical, commercial, and after-sales service aspects of the acquisition project, and publish bidding notices on designated disclosure media; The evaluation expert group determines the winning supplier based on the bidding response and evaluation rules of the tenderer; Finally, the acquirer and the winning supplier sign the acquisition contract.
(4) Characteristics of Medical Device Acquisition
Medical devices, as a special commodity, have their own uniqueness compared to other types of products. The accuracy, treatment effectiveness, and safety of medical equipment diagnosis results are closely related to the safety of the public's lives. Medical devices have strong efficiency, fast technological updates, complex brand types, and require strong professionalism. They belong to typical technology intensive products with a high degree of specialization, complex product varieties, and inconsistent professional standards. Acquisition requires simple and biased judgments.

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