Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code

The Ministry of Health of Vietnam issued several new regulations that took effect from July 1st, 2023. The following is the summary of how the regulations may have affected the provision of medical devices in the Vietnamese Market. 

Circular No. 14/2023/TT-BYT stipulated the order and procedures for formulating bidding packages for procurement of goods and provision of services in the field of medical devices at public health facilities. This circular will be effective starting July 1st, 2023, until December 31st, 2023. When formulating bidding packages, investors shall use any of the following methods:

    • By collecting quotations provided by traders of goods and services in the field of medical devices.
    • By conducting a survey on the winning bid price of similar goods and services on the e-Government System.
    • The prices appraisal results from competent state agencies and price appraisal enterprises.

After one month of effectiveness, Circular 14/2023/TT-BYT has helped the hospitals to resolve the difficulties in bidding, helping to overcome the current situation of medical facilities bidding. For more details on the regulation, please click here.

Another circular also came into effect, Circular No. 44/2023/TT-BTC stipulating the rate of collection of some fees and charges to support people and businesses. This Circular was issued by the Ministry of Finance and is valid until December 31, 2023. According to this circular, the Ministry of Finance will reduce the collection rate ranging from 10% to 50% for 36 different types of fees and charges, to support people and businesses. Accordingly, the fee in the medical field will be reduced by 30%. For more details on the regulation, please click here.

In addition, the Ministry of Health is also drafting a Circular promulgating a list of medical devices with HS codes according to the list of exported and imported goods in Vietnam. The list includes 99 items that are identified as medical devices, as prescribed in the Decree on management of medical equipment and other legal documents on medical devices. However, in an event the HS code is not found, a customs declaration shall be made according to the actual description of the goods and the list of exported and imported goods in Vietnam. After customs clearance, exporting and importing organizations and individuals shall send the documents to the Ministry of Health (Department of Infrastructure and Medical Equipment) to coordinate with the Ministry of Finance (General Department of Customs) to consider unify, update, and promulgate the Supplemental List

This draft Circular is expected to be issued in 2023 and will replace the Circular No. 14/2018/TT-BYT dated May 15, 2018, promulgating the list of medical equipment with defined codes number of goods according to the list of exported and imported goods in Vietnam. The draft Circular, in Vietnamese, can be accessed here.

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