Vietnam: Application for approval for the medical device contractor selection plan from September 01, 2020

According to Circular No. 14/2020/TT-BYT of the Ministry of Health of Vietnam, in addition to regulations of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, an application for approval for the contractor selection plan shall include at least the following documents:

- The written request for approval for the contractor selection plan.

- Relevant documents and legal documents.

- Brief report on execution of the preceding year’s contractor selection plan and use of medical devices (if any) and brief description of the contractor selection that needs approval.

- The documents that are the basis for preparation of the contractor selection plan prescribed in Clause 1 Article 6 of this Circular.

- The minutes of the meeting of the science council of the health facility expressing consensus on the plan, necessity, devices, quantity, technical requirements and cost estimate. The meeting must be attended by representatives of relevant departments/wards and the unit that will use the medical devices.

- The documents that are the basis for estimating the contract value prescribed in Article 8 of this Circular.

Circular No. 14/2020/TT-BYT also specifies contract value as follows:

- The contract value shall be estimated according to the total investment or cost estimate of the project, and is inclusive of all costs, cost contingency, fees, charges and taxes. In case a contract is divided into multiple parts, each of them shall have a list of products, their qualities, units, unit prices and value of that part as prescribed.

- When estimating the contract value, the health facility shall examine the successful bids within the last 12 months on the website of the authority that has the power to approve the contractor selection plan and the Ministry of Health. To be specific:

+ The reserve price of a device must not exceed the successful bid of the same device or the announced successful bid. Otherwise, explanation shall be provided;

+ In case a successful bid is not available, the contract value shall be estimated according to the documents prescribed in the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and instructional documents on contract valuation and market price of the device at the time when the contractor selection plan is prepared.

View full text in Circular No. 14/2020/TT-BYT of the Ministry of Health of Vietnam, which takes effect from September 01, 2020.

Thu Ba

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