Vietnam

The Drug Administration of Vietnam (DAV), operating under the Ministry of Health (MOH), serves as the primary regulatory authority responsible for overseeing the registration, licensing, and post-market surveillance of health products including pharmaceuticals, medical devices, diagnostics, and digital health solutions. The principal governing legislation includes the Law on Pharmacy No. 105/2016/QH13 (amended by Law No. 03/2022/QH15), the Law on Medical Examination and Treatment, and various MOH circulars and decrees that provide specific guidance for each product category. Medical devices are governed separately under Decree No. 98/2021/ND-CP and its subsequent amendments, which establish a risk-based classification system (Class A through Class D) analogous to international frameworks. All health products must obtain marketing authorization from the DAV or relevant MOH department before commercial distribution, with the review process involving technical dossier assessment, quality evaluation, and in some cases local clinical or performance data requirements.

Applicants are required to appoint a locally registered legal entity or authorized representative based in Vietnam to submit and maintain product registrations. Dossiers are generally accepted in formats aligned with the ASEAN Common Technical Dossier (ACTD) for pharmaceuticals and the ASEAN Medical Device Directive (AMDD) framework for devices, with increasing alignment toward ICH Common Technical Document (CTD) standards for innovative medicines. Vietnam has introduced an expedited review pathway for products pre-approved by stringent regulatory authorities (SRAs) recognized by the MOH, including the US FDA, EMA, and agencies from Japan, Australia, and Canada, which can significantly shorten timelines for eligible products. Recent reforms under the amended Pharmacy Law and revised medical device decrees have aimed to streamline the registration process, introduce electronic submission portals, reduce duplication for products with prior SRA approval, and strengthen post-market surveillance obligations, reflecting Vietnam's broader ambition to harmonize with ASEAN and international regulatory standards.

Public procurement of health products in Vietnam is centrally coordinated through the Ministry of Health, with the MOH issuing national bidding guidance, approved product lists, and price ceilings that govern purchasing across public health facilities. The legal framework is anchored in the Law on Bidding No. 22/2023/QH15 and associated MOH circulars that regulate the tendering, evaluation, and contracting processes for pharmaceuticals, medical devices, and diagnostics in the public sector. Procurement occurs at multiple levels: centralized national tenders managed by the MOH for high-volume or strategic products, provincial-level tenders coordinated by Provincial Health Departments, and facility-level procurement for products outside centralized frameworks. All public procurement must comply with price negotiation mechanisms and approved bidding packages, with product eligibility contingent on valid MOH registration and listing on approved formularies or device catalogs. State-owned hospitals and district health centers are primary institutional buyers, and budget constraints frequently influence formulary decisions and volume uptake.

The private healthcare sector in Vietnam is expanding rapidly, comprising private hospitals, international clinics, pharmacy chains, and diagnostic laboratories that procure health products through direct commercial channels, distributor agreements, and import licenses, largely independent of the public tender system. This segment represents a growing market for premium and innovative health products. Vietnam also receives support from international donor and financing organizations including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance, which fund procurement of vaccines, diagnostics, and essential medicines primarily for public health programs targeting HIV, tuberculosis, malaria, and immunization. These donor-funded channels often follow international procurement standards such as WHO prequalification requirements. The Vietnamese government has implemented policies promoting local manufacturing preferences in public tenders, particularly favoring domestically produced pharmaceuticals and medical devices under specific bidding group categories, as part of its broader industrial and self-sufficiency strategy articulated in national pharmaceutical and health industry development plans.