Vietnam

The primary regulatory authority for health products in Vietnam is the Drug Administration of Vietnam (DAV), operating under the Ministry of Health (MOH). The main governing legislation includes the Law on Pharmacy No. 105/2016/QH13 (amended by Law No. 03/2019/QH14), Decree 54/2017/ND-CP, and Decree 155/2018/ND-CP, which together establish the framework for registration, importation, circulation, and post-market surveillance of pharmaceuticals, medical devices, and diagnostics. Digital health products and software as a medical device are increasingly addressed through supplementary circulars and guidance issued by the MOH. All health products must obtain a Marketing Authorization (MA) or a Certificate of Free Sale (CFS) recognition before they may be legally distributed in Vietnam, with the DAV serving as the central reviewing and approving body.

Foreign manufacturers seeking market authorization in Vietnam are required to appoint a locally registered entity, either a wholly foreign-owned enterprise or a Vietnamese company, to act as the local representative and MA holder. Dossier submissions generally follow the ASEAN Common Technical Dossier (ACTD) format for pharmaceuticals, while medical devices follow the ASEAN Medical Device Directive (AMDD) framework. Vietnam has progressively aligned with ASEAN Harmonization initiatives and recognizes approvals from stringent regulatory authorities (SRAs) such as the US FDA, EMA, and Japan PMDA under an expedited or abridged review pathway. Notable recent reforms include the introduction of Circular 08/2022/TT-BYT for medical device registration, which restructured device classification into four risk-based classes (A, B, C, D) and streamlined documentation requirements, as well as ongoing digitization of the submission and licensing process through the National Public Service Portal.

Public procurement of health products in Vietnam is centrally governed by the Ministry of Health in coordination with the Ministry of Finance and the Ministry of Planning and Investment, under the overarching Public Procurement Law No. 43/2013/QH13 (amended by Law No. 58/2020/QH14) and its associated decrees. Procurement is conducted at multiple levels: national centralized tendering managed by the MOH for essential medicines and strategic health commodities, provincial-level tendering coordinated by Provincial Health Departments (PHDs), and facility-level procurement for hospitals classified as autonomous public institutions. The National Center for Pharmaceutical Tendering under the DAV oversees the national drug tender process, which groups products into bid packages by active ingredient, concentration, and dosage form. Public hospitals are required to procure through these established tender frameworks, and price ceilings are set by the MOH to control expenditure. Medical devices and diagnostics procured for public facilities are subject to separate tendering procedures, often managed at the hospital or provincial level, and must comply with Decree 151/2017/ND-CP and related guidance on asset procurement.

The private healthcare sector in Vietnam is rapidly expanding and represents a significant procurement channel operating largely outside the public tender system, with facilities sourcing products directly from licensed importers and distributors. International and donor-funded procurement channels also play a role, particularly in communicable disease programs: organizations such as the Global Fund (for HIV, tuberculosis, and malaria), UNICEF, USAID through PEPFAR, and Gavi the Vaccine Alliance supply health commodities in coordination with the MOH and the Vietnam Administration of HIV/AIDS Control (VAAC). These donor channels often leverage international procurement mechanisms and may import products under special authorization or waiver provisions. Vietnam maintains a stated policy priority of promoting domestic pharmaceutical manufacturing, reflected in preferential scoring for locally produced products in public tenders, incentives under the Pharmaceutical Industry Development Strategy to 2030, and requirements for technology transfer arrangements with foreign partners where feasible.