Vietnam: Extension on Medical Device Import Licenses

On January 1, 2025, the Government of Vietnam issued Decree No. 04/2025/ND-CP, amending and supplementing several articles of Decree No. 98/2021/ND-CP regarding the management of medical devices. The decree extends the validity of medical device import licenses as follows:

  • Import licenses for medical devices issued from January 1, 2018, to December 31, 2021, remain valid until June 30, 2025, with no quantity restrictions.
  • Class C and D medical devices without an import license—excluding certain insecticidal and germicidal products—can be imported with classification results published on the Ministry of Health’s online portal until June 30, 2025, without quantity restrictions or additional documentation.
  • Registration numbers for in vitro diagnostic biological products issued from January 1, 2014, to December 31, 2019, remain valid until June 30, 2025.
  • Import licenses under Clause 4, Article 76 of Decree No. 98/2021/ND-CP are valid until June 30, 2025.

Further Information

For additional details, consult the official guidance document: Decree 04_2025_ND-CP_639587.pdf (in Vietnamese).

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