Illustration: Pharmaceutical laboratory — Source: Wikimedia Commons (CC).
A French pharmaceutical group wants to bring a new oncology drug to Vietnam while distributing its own line of diagnostic imaging equipment. Its legal team discovers the two products travel in two completely different legal lanes in Vietnam — and taking the wrong lane costs years.
Vietnam regulates pharmaceuticals and medical devices under two separate legal systems. French businesses must pick the right lane from the start.
Lane 1: Drugs — circulation registration under the new Law on Pharmacy
The current framework for drugs comprises: the Law on Pharmacy per Consolidated Document 39/VBHN-VPQH (issued 27 February 2025, consolidating Law on Pharmacy 105/2016/QH13 with amending laws including Law 44/2024/QH15); Law 44/2024/QH15 effective from 1 July 2025 (some provisions from 1 January 2025); Decree 163/2025/ND-CP (29 June 2025) detailing implementation; and Circular 32/2026/TT-BYT (29 July 2026, effective 1 October 2026) on the circulation registration of drugs and drug ingredients.
What French companies should note:
First, circulation registration is the mandatory gate. A drug may only circulate in Vietnam after its circulation registration certificate is granted. Registration files now follow Circular 32/2026/TT-BYT — the newest instrument, effective 1 October 2026. Businesses that filed under the old rules before that date should review the transitional provisions.
Second, distinguish chemical drugs, biologics and traditional medicines. Each group faces different technical file requirements (clinical trials, bioequivalence and so on). A new drug like the oncology product in the opening example typically requires full clinical-trial data.
Third, drug prices are regulated. The Law on Pharmacy governs drug price management (declaration and publication of prices). French companies should build pricing strategy from the registration stage, because price directly affects the ability to win tenders into public hospitals — the main channel for prescription drugs.
Lane 2: Medical devices — circulation numbers under Decree 98/2021 (as amended)
Medical devices in Vietnam are governed by Decree 98/2021/ND-CP, amended by Decree 07/2023/ND-CP and Decree 04/2025/ND-CP (consolidated document 08/VBHN-BYT of 2026). The key point: the ASEAN Common Submission Dossier Template (CSDT) has been mandatory since 1 January 2024.
For the French group’s diagnostic imaging line — high-risk equipment — the business must classify the risk level and obtain the corresponding circulation number. The CSDT file requires complete technical documentation, and device labelling must comply with current labelling rules (mandatory contents, Vietnamese supplementary labels where required).
A caution: some secondary sources mention a Decree 37/2026/ND-CP on medical devices, but we could not verify this instrument through official sources — businesses should rely on the latest consolidated document 08/VBHN-BYT rather than unverified information.
Three strategic decisions before market entry
Choose the presence model. A French company may export via a Vietnamese distributor, open a representative office, or incorporate locally. Each model carries different legal duties on registration ownership (who holds the registration certificate), pharmacovigilance and tax. Foreign investment conditions in pharmaceutical distribution carry their own restrictions — check current rules before deciding.
Model the EVFTA advantage. The EVFTA phases out tariffs for many EU-origin pharmaceutical and device lines — but the exact rate must be looked up by HS code in the tariff schedule. Never assume “French goods get zero.”
Prepare for tenders. Public hospitals account for a large share of drug and device consumption in Vietnam. Registration certificates, declared prices and supply capacity must be ready before tender season — missing one cycle can cost a full year.
Frequently asked questions
A drug already authorised in France (EMA) — is it “recognised” in Vietnam?
Not automatically. Vietnam has mechanisms referencing decisions of stringent regulatory authorities (SRAs) in some cases, but a Vietnamese circulation registration procedure is still required. Check the current scope of application.
Can a French company’s representative office hold the registration certificate?
Check current rules on who may hold a circulation registration certificate — normally a legal entity or a duly authorised party. Confirm with counsel before filing.
Class A (low-risk) medical devices — do they need a circulation number?
Devices are classified by risk (A, B, C, D) with different management requirements. Classification must be done first; never assume “low risk means no procedure.”
Does changing distributors affect the registration certificate?
It can. The certificate holder and the distributor are distinct but closely linked legal roles — changing the importing/distributing party may require amendment filings. Check before terminating the old distribution contract.
This article has been quality-reviewed by the FLAW AI Legal Council
