Vietnam Moves Medical Device Inspection Milestones to 2027 and 2028

Vietnam's Ministry of Health issued Circular No. 24/2026/TT-BYT on 30 June 2026, effective 1 July 2026. Its signed text, articles 3–4, amends the inspection roadmap in Circular 05/2022/TT-BYT and repeals Circular 59/2025/TT-BYT. It does not replace Circular 05/2022 as a whole.

For suppliers and buyers of the six listed device categories, the material change is a later purchase-date cutoff and a later completion deadline for safety and technical-performance inspection, known as kiểm định.

The previous and revised milestones

The earlier roadmap under Circular 59/2025 used purchases after 30 June 2026 as one cutoff. Devices purchased before 1 July 2026 had to complete inspection before 31 December 2026. Those earlier requirements and the six device categories are set out in the Lang Son Department of Health's February 2026 implementation notice, which implements the Ministry's letter 1051/BYT-HTTB.

Circular 24/2026 replaces article 8 with the following arrangements:

1. Purchases after 30 June 2027: the device must undergo safety and technical-performance inspection following the procedures issued by the Minister of Health. This covers purchases from 1 July 2027 onward.
2. Purchases before 1 July 2027: inspection must be completed before 1 January 2028, following those procedures. The operative wording is “before,” not an inclusive deadline on 1 January.

The new article uses purchase timing to determine the applicable arrangement. It does not itself specify a tender-stage certificate requirement, who pays, or the exact point during a purchase at which inspection must occur.

Which devices are covered?

The roadmap refers specifically to clauses 1–6 of article 5 of Circular 05/2022. That list comprises ventilators, anaesthesia machines with ventilation, high-frequency electrosurgical units, infant incubators, defibrillators and haemodialysis machines. It is not a new inspection obligation for every medical device or IVD.

The February implementation notice describes the earlier timetable. For the current purchase-date cutoff and completion deadline, use the replacement article 8 enacted by Circular 24/2026.

Classification and HS codes

Article 2(1) of Circular 24/2026 states that device risk-level determination and corresponding management measures follow Decree 98/2021/NĐ-CP and its implementing documents. Article 2(2) refers HS codes to Circular 19/2024/TT-BYT. These provisions do not establish a replacement device-classification system.

The wider product-quality framework is separate from the particular device inspection dates. Manufacturers should keep this inspection review distinct from Vietnam classification and grouping and device-labeling requirements.

Practical implications for suppliers and buyers

Pure Global's analysis is that hospitals, other buyers, suppliers and local regulatory teams should coordinate inspection planning by device category and documented purchase date. For purchases before 1 July 2027, plan completion before 1 January 2028. For later purchases, establish the applicable inspection arrangement under the Ministry's procedures.

Suppliers can support buyers by identifying covered models, supplying the technical documentation needed for inspection and agreeing who organizes and pays for it. These are practical recommendations; the circular does not assign all inspection responsibility exclusively to buyers or create a universal manufacturer-paid requirement. It also does not itself require reclassification or a new registration filing solely because the inspection roadmap changed.