Extension of medical equipment import license until June 30, 2025

The Government issued Decree No. 04/2025/ND-CP amending and supplementing a number of articles of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management, which has been amended and supplemented by a number of articles under Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government.

The Government issued Decree No. 04/2025/ND-CP amending and supplementing a number of articles of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management, which has been amended and supplemented by a number of articles under Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government.

Illustration photo. (Source: Internet)

Extension of medical equipment import license until June 30, 2025

Decree No. 04/2025/ND-CP amends and supplements Clause 2, Article 76 of Decree No. 98/2021/ND-CP regulating the value of import licenses; regulating the import of medical equipment not on the list of medical equipment requiring an import license:

a) Import licenses for medical devices other than in vitro diagnostic biological products issued from January 1, 2018 to December 31, 2021 shall continue to be used until June 30, 2025 (the old regulation was December 31, 2024);

b) Import licenses for medical devices that are in vitro diagnostic biological products that have been granted from January 1, 2018 to December 31, 2021 will continue to be used until June 30, 2025 (the old regulation is December 31, 2024), and there is no limit on the import quantity.

c) Organizations that have been granted import licenses as prescribed in Points a and b above must satisfy the conditions prescribed by law and must be responsible for ensuring the quality, quantity, type and purpose of use of imported medical equipment. The Ministry of Health is responsible for inspecting, examining and revoking import licenses in cases of violations of regulations on medical equipment management;

d) For medical equipment that is not on the list requiring an import license (except for chemicals, insecticides, disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment) and is classified as a type C or D medical equipment, information is published on the Ministry of Health's Electronic Information Portal, it can continue to be imported until June 30, 2025 (the old regulation is December 31, 2024) without quantity restrictions, without a document from the Ministry of Health confirming that it is a medical equipment and regardless of the time of information publication on the Ministry of Health's Electronic Information Portal when carrying out customs clearance procedures.

When carrying out import procedures, importing organizations and individuals must declare information about the number of documents issuing the results of medical equipment classification performed by themselves or requested by them to a qualified organization to perform the classification and are responsible for ensuring the quality, quantity, type, and purpose of use of imported medical equipment.

Customs authorities shall verify and compare information in the document issuing the results of medical equipment classification of importing organizations and individuals who have declared information on the Ministry of Health's electronic information portal.

Extension of registration number for circulation of medical equipment as in vitro diagnostic biological products

Decree No. 04/2025/ND-CP also amends and supplements Point c, Clause 3, Article 76 of Decree No. 98/2021/ND-CP regulating the value of circulation numbers, circulation registration certificates, and circulation registration numbers.

Accordingly, the circulation registration number for medical devices that are in vitro diagnostic biological products that were granted from January 1, 2014 to December 31, 2019 will continue to be used until June 30, 2025 (the old regulation was December 31, 2024).

Source: https://baodautu.vn/gia-han-giay-phep-nhap-khau-thiet-bi-y-te-den-het-ngay-3062025-d240713.html