Decree 04/2025/ND-CP amend Decree 98/2021/ND-CP on management of medical equipment, amended and supplemented under Decree 07/2023/ND-CP

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical equipment, which had a number of articles amended and supplemented under the Government's Decree No. 07/2023/ND-CP of March 3, 2023

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Pursuant to the Law on Organization of the Government dated June 19, 2015 and the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree amending and supplementing a number of articles of Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical equipment, which had a number of articles amended and supplemented under Decree No. 07/2023/ND-CP of March 3, 2023, of the Government.

Article 1. Amending and supplementing Clause 2, Clause 3, Clause 4 Article 76 of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical equipment, which had a number of articles amended and supplemented under the Government's Decree No. 07/2023/ND-CP of March 3, 2023, as follows:

1. To amend and supplement Clause 2 Article 76 of Decree No. 98/2021/ND-CP as follows:

“2. Regulations on the validity of import licenses; regulations on the import of medical equipment not on the list of medical equipment subject to import licensing:

a) Import licenses for medical equipment other than in-vitro diagnostic biologicals that were granted between January 1, 2018, and December 31, 2021, are valid by the end of June 30, 2025;

b) Import licenses for medical equipment being in-vitro diagnostic biologicals that were issued between January 1, 2018, and December 31, 2021, are valid by the end of June 30, 2025, and no limit on the quantity of imports shall be applied;

c) Organizations that have been granted import licenses specified at Points a and b of this Clause must satisfy the conditions prescribed by law and shall be held responsible for the quality, quantity, categories and use purposes of the imported medical equipment. The Ministry of Health shall inspect, examine, and revoke import licenses in case of violations of regulations on management of medical equipment;

d) For medical equipment which are not on the list of medical equipment subject to import licensing (except chemicals, insecticides and germicides for household and medical use that are used only for disinfecting medical equipment), if the documents classifying them as medical devices of category C or D have been published on the Ministry of Health’s Portal, they may continue to be imported by the end of June 30, 2025, without being subject to any limitations on the quantity of imports and when going through customs clearance procedures, the Ministry of Health’s confirmation of medical equipment shall not be required, regardless of the time of information disclosure on the Ministry of Health’s Portal.

When carrying out import procedures, importers shall declare the serial numbers of documents on results of classification of medical equipment which are conducted by the importers themselves or by organizations qualified to classify medical equipment at the importers’ request and shall be held responsible for the quality, quantity, categories and use purposes of the imported medical equipment.

Customs offices shall check and collate the information in the documents on results of classification of medical equipment declared by importers on the Ministry of Health’s Portal.”.

2. To amend and supplement Point c Clause 3 Article 76 of Decree No. 98/2021/ND-CP as follows:

“c) Circulation registration numbers of in-vitro diagnostic biologicals that were granted between January 1, 2014, and December 31, 2019, are valid by the end of June 30, 2025;”.

3. To amend and supplement Point d Clause 4 Article 76 of Decree No. 98/2021/ND-CP as follows:

“d) Import licenses granted under this Clause are valid by the end of June 30, 2025.”.

Article 2. Effect

This Decree takes effect from the date of its signing.

Article 3. Responsibilities of implementation

1. The Minister of Health shall provide instructions, organize and inspect the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees and related agencies, organizations and individuals shall implement this Decree.