Vietnam Import Licence: Decree 98 Article 48 and Product Scope
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Does every device imported into Vietnam need an import licence?
A: No. The standard route is a circulation registration number (số lưu hành) for Class C/D or a Declaration of Applicable Standards for Class A/B. The import licence (Giấy phép nhập khẩu) is the document required in the specific cases set out in Article 48 of Decree 98; it is an exceptional channel.
Q: Which cases does Article 48 list?
A: The cases listed in Article 48 of Decree 98 include, subject to the text of the decree: devices intended for aid and humanitarian assistance, gifts and donations, and trade fairs, exhibitions and product displays or introductions; and devices meeting urgent needs such as national defence, security, epidemic control and the handling of natural disasters and their consequences.
Q: Which products historically required an import licence?
A: Before and around the entry into force of Decree 98, Circular 30/2015/TT-BYT listed the product categories requiring an import licence for registration or import. Typical examples were X-ray therapy equipment, endoscopic surgical systems, radiotherapy equipment (cobalt-60 units, linear accelerators, gamma knives of all types), patient monitors, infusion and electric syringe pumps, high-frequency electrosurgical, laser and ultrasonic scalpels, surgical microscopes, prostate surgery systems, heart-lung machines, surgical positioning equipment, cryosurgical equipment and infant incubators. Under the current system these categories follow the Class C/D circulation registration route.
Q: What use is an import licence once the transition period has ended?
A: It remains available, but narrowed to the exceptional cases in Article 48. One point needs clarifying: Decree 04/2025 extended to 30 June 2025 the arrangement allowing Class C/D products not on the import licence list to be imported on the basis of a classification result document, and extended the validity of import licences issued between 2018 and 2021 to the same date. Both arrangements have now expired. From 1 July 2025, routine commercial import of Class C/D devices requires a circulation registration number, and import on a classification document no longer exists.
Q: What is the fee?
A: Under the reduced-period rates published in MOH Notice 645/TB-HTTB (2 July 2025), the review fee for an import licence application is VND 1,000,000 during the reduced period. For export licences, an application for an export licence for Class C/D devices reviewed by the MOH is VND 500,000, and for Class A/B devices reviewed at provincial level, VND 500,000. All are reduced-period rates; the rate published at the time of filing prevails.
Practical note: for exhibition samples, donated equipment and epidemic-control supplies, the first step is to decide whether the case falls within the Article 48 exceptions. If it does, apply for an import licence; if not, the routine registration route applies. Do not assume that “exhibition samples need no formalities”, and do not assume that “a donation will always qualify for a licence”. Either assumption leaves goods stranded at the port of entry.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 48 (cases requiring an import licence); (2) Decree No. 04/2025/NĐ-CP, Article 1 (transitional arrangements extended to 30 June 2025, now expired); (3) Circular No. 30/2015/TT-BYT (historical import licence list, for reference); (4) MOH Notice No. 645/TB-HTTB (2 July 2025), import and export licence review fees; (5) the MOH delegation decision assigning import licence issuance to IMDA.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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