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 the management of medical equipment, which was amended and supplemented by Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government.
Extending import licenses for medical equipment 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 the management of medical equipment, which was amended and supplemented by Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government.
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| Illustrative image. (Source: Internet) |
Extension of import licenses for medical equipment 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; and regulates the import of medical equipment not included in the list of medical equipment requiring import licenses.
a) Import licenses for medical devices other than in vitro diagnostic biological products issued from January 1, 2018 to December 31, 2021 will continue to be valid until June 30, 2025 (the old regulation was December 31, 2024);
b) Import licenses for in vitro diagnostic biological devices issued between January 1, 2018 and December 31, 2021 will continue to be valid until June 30, 2025 (the old regulation was December 31, 2024), and there is no limit on the quantity imported.
c) Organizations that have been granted import licenses as stipulated in points a and b above must meet the conditions prescribed by law and must be responsible for ensuring the quality, quantity, type, and intended use of imported medical equipment. The Ministry of Health is responsible for conducting inspections, examinations, and revoking import licenses in cases of violations of regulations on the management of medical equipment;
d) For medical devices not included in the list requiring import licenses (except for chemicals, insecticides, and disinfectants used in the household and medical fields with the sole purpose of disinfecting medical devices) and classified as medical devices of type C or D, with information published on the Ministry of Health's electronic portal, importation may continue until June 30, 2025 (the old regulation was December 31, 2024) without quantity restrictions, without requiring confirmation from the Ministry of Health as medical devices, and regardless of the time of information publication on the Ministry of Health's electronic portal during customs clearance procedures.
Organizations and individuals importing medical devices must declare the number of the document issuing the classification results, whether they performed the classification themselves or requested a qualified organization to perform it, when carrying out import procedures. They are responsible for ensuring the quality, quantity, type, and intended use of the imported medical devices.
Customs authorities will verify and cross-check the information in the document issuing the classification results of medical devices that the importing organization or individual has declared on the Ministry of Health's electronic portal.
Renewal of marketing authorization number for medical devices that are 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, registration certificates, and circulation registration numbers.
Accordingly, the registration numbers for in vitro diagnostic medical devices issued from January 1, 2014 to December 31, 2019 will continue to be valid until June 30, 2025 (the old regulation was December 31, 2024).
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