Vietnam: Preparation of the bidding documents and request for proposals

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, the following regulations shall be complied with during preparation of the bidding documents or request for proposals:

- Classify medical devices in accordance with Article 4 of this Circular. Medical devices of the same category can be put into one or several groups according to their necessity, uses and values.

- Technical requirements of each device shall be established according to its necessity and uses. Technical requirements of specialized medical devices specified in Circular No. 08/2019/TT-BYT shall be established in accordance with Appendix IV hereof.

- Bidders shall be requested to provide the number of the certificate of submission of the declaration of eligibility for trading medical devices, market authorization or import license of the proposed devices in accordance with Decree No. 36/2016/ND-CP, which is amended by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP.

- Specify the responsibilities of the contractor for transfer, installation and training to ensure effectiveness, quality and safety of patients and users.

- Do not require or suggest bidders to offer import products if domestically manufactured or assembled products are qualified in terms of quality, quantity and prices; comply with incentive requirements (criteria, incentive calculation and supporting documents) of bidding laws.

- Demand that the medical devices are provided by one of the following organizations and individuals:

+ Holders of marketing authorization number of the medical devices;

+ Authorized holders of marketing authorization number of the medical devices;

+ Organizations and individuals authorized by the organizations and individuals mentioned in Point b of this Clause;

+ Organizations and individuals authorized by the owner of the medical devices;

+ Organizations and individuals authorized by the organizations and individuals mentioned in Point d of this Clause;

+ Organizations and individuals authorized by the organizations and individuals mentioned in Point dd of this Clause;

+ The holder of the license to import medical devices;

+ Organizations and individuals authorized by the organizations and individuals mentioned in Point g of this Clause.

Note: Authorization shall comply with civil laws.

More details can be found 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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