Trading Eligibility in Vietnam: Decree 98 Article 40 Requirements

Q: What qualifications are needed to sell Class B/C/D devices in Vietnam?

A: The company must complete the Trading Eligibility Declaration (Bản công bố đủ điều kiện mua bán trang thiết bị y tế) and meet the conditions set by Article 40 of Decree 98/2021/NĐ-CP. Class A devices are not subject to this requirement, and that is the key difference on the company side between Class A and Class B/C/D.

Q: What does Article 40 require in practice?

A: Three basic conditions:

1. Technical staff — at least one technical member holding one of the following:
   • a college diploma or higher in engineering, medicine, pharmacy, chemistry or biology; or
   • a college diploma or higher in medical device technology; or
   • a college diploma or higher in a discipline relevant to the type of device traded;
2. Warehousing and transport — the warehouse must suit the type and quantity of devices stored, be well ventilated, dry, clean and away from sources of contamination, and meet any further storage requirements in the device’s instructions for use; vehicles must suit the devices carried. Where there is no owned warehouse or vehicle, a warehousing and transport contract must be signed with a qualified service provider;
3. Additional requirements for anaesthetics and precursors — for devices containing narcotic substances or precursors, the technical lead must hold a bachelor’s degree or higher in medical devices, medicine, pharmacy, medicinal chemistry or biology, a compliant warehouse must be in place, and an import, export and inventory tracking system must be established.

Q: How are these conditions evidenced?

A: Article 41(1) of Decree 98 sets out the declaration dossier: the Trading Eligibility Declaration document (per the MOH template), a personnel declaration form, documents evidencing warehousing and transport conditions (to be self-certified by the declaring entity), and, where applicable, documents on the warehousing and tracking system for narcotic substances and precursors.

Q: Which authority receives the declaration?

A: The provincial Department of Health (Sở Y tế) where the trading premises are located. Under the administrative procedure list published in Decision 2495/QĐ-BYT (4 August 2025), Trading Eligibility Declarations for Class B/C/D devices are handled by the health specialised agency under the provincial People’s Committee (the Department of Health).

Q: What follows the declaration?

A: Two things. (1) Once the Department of Health receives a complete dossier, including evidence of the fee paid under Ministry of Finance rules, it publishes the declaration on the medical device management portal. (2) If the declared information changes in the course of trading, the entity must notify in writing with supporting documents and update the published dossier on the portal within 3 working days of the change (Article 41(2)).

Practical note: treat the “technical staff qualification evidence” and the “warehousing/transport contract” as pre-contract checks, not items to fix after signing. These two are the most frequently sampled in inspections, and remediation is slow once they fail, because staff must be recruited and warehouses modified. When selecting a partner, ask for scanned copies of both documents and verify them.

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 40 (personnel, warehousing and transport, additional conditions for anaesthetics and precursors); (2) Decree 98/2021/NĐ-CP, Article 41 (dossier content and procedure, 3-working-day update); (3) Decision No. 2495/QĐ-BYT (4 August 2025), administrative procedure list, item II.12 (provincial Department of Health as the handling level) and the corresponding fee; (4) MOH Notice No. 645/TB-HTTB (2 July 2025) on fees.