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. 61/2020/QH14), Decree 54/2017/ND-CP, and Circular 08/2022/TT-BYT for pharmaceuticals, alongside Circular 05/2022/TT-BYT and related instruments for medical devices and diagnostics. Digital health products are increasingly subject to MOH guidance under the National Digital Health Strategy to 2025. All health products must undergo a formal registration and marketing authorization process through DAV prior to commercialization, with submissions evaluated for safety, efficacy, and quality based on technical dossiers. Medical devices are classified into four risk categories (Class A through D), with higher-risk devices requiring more rigorous pre-market review, while lower-risk devices may follow a simplified declaration pathway.

Foreign manufacturers seeking to register health products in Vietnam are required to appoint a local authorized representative or import license holder, who acts as the legal entity responsible for the registration and post-market obligations. Vietnam generally accepts dossiers structured in accordance with the ASEAN Common Technical Dossier (ACTD) format for pharmaceuticals, and aligns with ASEAN Medical Device Directive (AMDD) standards for medical devices. Notably, Vietnam has been implementing significant regulatory modernization efforts, including the acceptance of marketing authorization approvals from stringent regulatory authorities (SRAs) such as the US FDA, EMA, and others as a basis for expedited review pathways. Recent reforms under Decree 155/2018/ND-CP and subsequent circulars have streamlined device registration timelines and introduced electronic submission portals, though administrative bottlenecks and capacity constraints remain practical challenges for applicants.

Public procurement of health products in Vietnam is centrally coordinated through the Ministry of Health, with the Vietnam Social Security (VSS) playing a critical role in reimbursement and formulary decisions for pharmaceuticals and medical devices used in public hospitals. National-level centralized tendering is managed by DAV and the MOH Procurement and Supply Management Division, while provincial health departments conduct their own procurement processes for locally managed facilities. The bidding framework is governed by the Law on Bidding No. 43/2013/QH13 (updated by Law No. 22/2023/QH15 effective 2024) and associated decrees, which establish multi-category tender groups for pharmaceuticals (e.g., branded originator, generic Group 1-5) and separate procurement tracks for medical devices and consumables. Public hospital procurement is predominantly volume-driven and price-sensitive, with price negotiation and ceiling prices set by MOH playing a determining role in market access outcomes.

The private healthcare sector in Vietnam is expanding rapidly and represents a significant and growing procurement channel, particularly for premium diagnostics, medical devices, and innovative pharmaceuticals, operating largely outside the centralized tender framework and driven by direct commercial negotiations. Donor-funded procurement through multilateral agencies including UNICEF, the Global Fund, USAID, and Gavi remains relevant for specific disease areas such as HIV/AIDS, tuberculosis, malaria, and immunization programs, often following international procurement standards (e.g., WHO prequalification) rather than domestic registration requirements. Vietnam has articulated policies encouraging local pharmaceutical and medical device manufacturing, including preferential scoring in tenders for domestically produced products and incentives under the Pharmaceutical Industry Development Strategy to 2030. Joint ventures and technology transfer arrangements with local manufacturers are increasingly viewed as strategically advantageous for foreign companies seeking sustained public market access.