Modification of transitional provisions regarding the validity of medical equipment import licenses in Vietnam

Modification of transitional provisions regarding the validity of medical equipment import licenses in Vietnam

The Decree 04/2025/ND-CP has amended and supplemented Clause 2, Article 76 of Decree 98/2021/ND-CP by revising regulations regarding the value of import licenses; and stipulating the importation of medical devices not on the list of those requiring import licenses in Vietnam:

- Import licenses for medical devices, which are not in vitro diagnostic biological products and have been issued from January 1, 2018, to December 31, 2021, may continue to be used until June 30, 2025;

- Import licenses for medical devices that are in vitro diagnostic biological products and have been issued from January 1, 2018, to December 31, 2021, may continue to be used until June 30, 2025, without restriction on import quantity;

- Organizations holding import licenses as stipulated in points a and b of this clause must comply with legal conditions and are responsible for ensuring the quality, quantity, type, and purpose of use of imported medical devices. The Ministry of Health of Vietnam is responsible for inspecting, monitoring, and revoking import licenses in cases of violations of medical device management regulations;

- For medical devices not on the list requiring import licenses (excluding chemicals, insecticidal and bactericidal preparations used in domestic and medical fields for the sole purpose of medical device disinfection) and classified as medical devices of type C, D that have information published on the Ministry of Health's electronic portal, they can continue to be imported until June 30, 2025, without quantity restriction and without needing a document from the Ministry of Health confirming that they are medical devices, regardless of the timing of information publishing on the electronic portal when carrying out customs clearance procedures.

Organizations and individuals importing medical devices must declare information about the document number issuing the classification result of the medical devices they conducted or requested a qualified organization to conduct, and be responsible for ensuring the quality, quantity, type, and purpose of use of the imported medical devices.

Customs authorities are responsible for checking against the information in the issued classification result document of medical devices provided by the importing organization, individual as declared on the Ministry of Health's electronic portal.

The Decree 04/2025/ND-CP will take effect from January 1, 2025.

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