Vietnam: Medical Device Import License Extended to 30 June 2025

The Ministry of Health of Vietnam (MOH) recently issued Decree No. 04/2025/ND-CP, introducing amendments and supplements to Decree No. 98/2021/ND-CP on medical equipment management. This latest decree also incorporates updates to Decree No. 07/2023/ND-CP, enhancing the regulatory framework governing the import and circulation of medical devices in Vietnam.

Extended Validity of Import Licenses

Decree No. 04/2025/ND-CP revises Clause 2, Article 76 of Decree No. 98/2021/ND-CP, extending the validity period for import licenses of medical equipment issued between 1 January 2018 and 31 December 2021:

• For medical devices other than in-vitro diagnostic biological products

  • Import licenses will now remain valid until 30 June 2025 (extended from 31 December 2024)

• For in-vitro diagnostic biological products

  • Import licenses will also remain valid until 30 June 2025 (extended from 31 December 2024), with no limit on import quantities

    
    

Organizations holding such licenses must meet all legal conditions and ensure the imported medical equipment's quality, quantity, type, and intended purpose. MOH will oversee compliance through inspections and revoke licenses in cases of violations.

Regulations for Medical Equipment Not Requiring Import Licenses

For medical devices that are not on the list requiring an import license (excluding chemicals, insecticides, and disinfectants used solely for disinfecting medical equipment) and classified as Type C or D, the following provisions apply:

• These devices can continue to be imported until 30 June 2025 (extended from 31 December 2024) without any restrictions on quantity

• Importers do not need a document from the MOH confirming the device’s classification as medical equipment

• Customs clearance procedures are unaffected by the date of information publication on the MOH’s electronic information portal

  
  

During the import process, importing organizations and individuals must

• Declare information regarding the classification results of medical devices, either performed internally or by a qualified organization

• Ensure the quality, quantity, type, and intended purpose of the imported devices

  
  

Extension of Circulation Registration Numbers

The decree also introduces changes to Point C, Clause 3, Article 76 of Decree No. 98/2021/ND-CP, extending the validity of circulation registration numbers for in-vitro diagnostic biological products:

• Registration numbers granted between 1 January 2014 and 31 December 2019 will now remain valid until 30 June 2025 (previously 31 December 2024)

  
  

Conclusion

This initiative represents the government’s commitment to streamlining the management of medical equipment imports and circulation in Vietnam. By extending validity periods and simplifying procedures, the decree aims to address challenges faced by importers and healthcare providers while maintaining strict quality control standards.

For further details or assistance with compliance, stakeholders are encouraged to consult with our team at info@arqon.com.

Source: Ministry of Health