Vietnam After 1 July 2025: Decree 04/2025 Transition Ends

This page is kept current: transitional provisions change with MOH announcements. Rely on the version officially published at the time, and watch for any further extension decree.

Q: What actually happened on 1 July 2025?

A: All transitional arrangements under Decree 98/2021/NĐ-CP lapsed and the decree moved to full enforcement. Decree 04/2025/NĐ-CP (in force 1 January 2025) had extended three arrangements to 30 June 2025:

1. Medical device import licences (other than those for in vitro diagnostic biological products) issued between 1 January 2018 and 31 December 2021 remained valid until 30 June 2025;
2. Import licences for in vitro diagnostic biological products issued in the same period remained valid until 30 June 2025, with no import quantity limit;
3. Circulation registration numbers for in vitro diagnostic biological products issued between 1 January 2014 and 31 December 2019 remained valid until 30 June 2025.

In addition, Class C and Class D products that were not on the import licence list and whose classification result had been published on the MOH portal could be imported on the classification document until 30 June 2025, with no quantity limit and without an MOH confirmation letter at customs. That provision also ended on the same date.

Q: After the transition ended, what does a Class C/D import require?

A: A circulation registration number (số lưu hành) issued by the MOH. The “import on a classification document” route no longer exists, and neither the extended old import licences nor the old IVD biological product circulation numbers can be used. A company that still needs to supply the market must file a full circulation registration application.

Q: What should holders of existing certificates do now?

A: Three steps. (1) Inventory: list every old import licence and old circulation number, separating those “extended to 30 June 2025” from those “already expired”. (2) Prioritise: rank by sales value and by the cost of a supply interruption, and protect the leading SKUs first. (3) File: for Class C/D, prepare the CSDT, LoA, CFS, ISO 13485 certificate and Vietnamese labels and IFU to current requirements, and take the fast track where it is available (a reference-country CFS or MA can shorten the timeline substantially).

Q: Is there a window in which products can still be sold while the new filing is pending?

A: There is no additional window. Article 22 of Decree 98 requires one of a circulation number, a circulation registration number, a circulation registration certificate or an import licence before a device may be placed on the market; statutory liquidation, expiry, failure to eliminate hazardous factors and use not permitted by the competent authority are excepted. Selling after the transition ended is unlicensed circulation and attracts the handling and penalty provisions of Decree 98.

Practical note: supply interruption can be hedged in advance. Three suggestions: (1) start the formal filing for leading SKUs at least six months before the transition ends; (2) where the fast track is not available, use an import licence (the Article 48 exceptions) to buy time, judging suitability case by case; (3) agree delivery schedules with hospitals early to avoid breaching tender commitments.

Verification checklist (26 October 2026): (1) the full text of Article 1 of Decree No. 04/2025/NĐ-CP (Article 76(2)(a) to (d), 76(3)(c) and 76(4)(d)) and Article 2 (in force from the date of signature); (2) Article 22 of Decree 98/2021/NĐ-CP (conditions for circulation, as amended by 07/2023); (3) the current text of the Article 76 transitional provisions of Decree 98/2021/NĐ-CP; (4) MOH/IMDA portal announcements on the end of the transition period (as published at the time).