Decree No. 04/2025/NĐ-CP Amending and supplementing certain articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical device management, which has been amended and supplemented by certain articles according to Decree No. 07/2023/NĐ-CP dated March 3, 2023 of the Government.

DECREE

Amending and supplementing certain Articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical device management which has been amended and supplemented certain Articles according to Decree No. 07/2023/NĐ-CP dated March 3, 2023 of the Government

Pursuant to the Law on Government Organization dated June 19, 2015; the Law amending and supplementing certain Articles of the Law on Government Organization and the Law on Local Administration dated November 22, 2019;

At the proposal of the Minister of Health;

The Government promulgates this Decree amending and supplementing certain Articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021 on medical device management which has been amended and supplemented certain Articles according to Decree No. 07/2023/NĐ-CP dated March 3, 2023 of the Government.

Article 1. Amending and supplementing Clause 2, Clause 3, Clause 4 Article 76 of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical device management which has been amended and supplemented certain Articles according to Decree No. 07/2023/NĐ-CP dated March 3, 2023 of the Government as follows:

1. Amending and supplementing Clause 2 Article 76 of Decree No. 98/2021/NĐ-CP as follows:

"2. Provisions on the value of import permits; provisions on importing medical devices not included in the list of medical devices requiring import permits:

a) Import permits for non-in vitro diagnostic medical products issued from January 1, 2018 to December 31, 2021 shall continue to be valid until June 30, 2025;

b) Import permits for in vitro diagnostic medical products issued from January 1, 2018 to December 31, 2021 shall continue to be valid until June 30, 2025 without limitation on the quantity of imports;

c) Organizations that have been granted import permits under points a and b of this clause must comply with the conditions stipulated by law and bear responsibility for ensuring the quality, quantity, type, and purpose of use of imported medical devices. The Ministry of Health shall be responsible for conducting inspections, examinations, and revoking import permits for cases violating regulations on medical device management;

d) For medical devices not included in the list requiring import permits (except chemicals, insecticides, and bactericides used solely for sterilizing medical devices in household and medical fields) and classified as Class C or D medical devices, information published on the Ministry of Health's electronic portal may continue to be imported until June 30, 2025 without limitation on quantity, without the need for a confirmation document from the Ministry of Health stating that they are medical devices, and without being subject to the time frame for publication on the Ministry of Health's electronic portal when performing customs clearance procedures.

When organizations or individuals import medical devices and perform import procedures, they must declare information about the issuance document number of the classification result of the medical devices conducted by themselves or requested from qualified organizations to conduct such classification, and bear responsibility for ensuring the quality, quantity, type, and purpose of use of imported medical devices.

Customs authorities shall check and compare the information in the issuance document of the classification result of the medical devices declared by organizations or individuals on the Ministry of Health's electronic portal.".

2. Amending and supplementing Point c Clause 3 Article 76 of Decree No. 98/2021/NĐ-CP as follows:

"c) Registration numbers for circulation for in vitro diagnostic medical products issued from January 1, 2014 to December 31, 2019 shall continue to be valid until June 30, 2025;"

3. Amending and supplementing Point d Clause 4 Article 76 of Decree No. 98/2021/NĐ-CP as follows:

"d) Import permits issued in accordance with this clause shall remain valid until June 30, 2025."

Article 2. Implementation clause

This Decree takes effect from the date of issuance.

This Circular takes effect from December 25, 2025/.

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees directly under the central government, and related agencies, organizations, and individuals shall be responsible for implementing this Decree./.