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 overarching legal framework is established by the Law on Pharmacy (Law No. 105/2016/QH13) and its subsequent amendments, supplemented by a series of Circulars and Decrees governing pharmaceuticals, medical devices, diagnostics, and digital health solutions. Pharmaceuticals require full registration with DAV before market entry, while medical devices and in-vitro diagnostics are classified into four risk-based categories (Class A through Class D) under Decree 98/2021/ND-CP, with Class A requiring declaration and higher-risk classes requiring full conformity assessment and registration. Digital health products are subject to evolving guidance from both the MOH and the Ministry of Information and Communications.

All foreign manufacturers seeking registration in Vietnam must appoint a local authorized representative or Marketing Authorization Holder (MAH), who bears full legal responsibility for the product on the Vietnamese market. Dossier submissions generally follow the ASEAN Common Technical Dossier (ACTD) format, although ICH CTD-aligned submissions are increasingly accepted for products already approved in stringent regulatory authority (SRA) jurisdictions such as the US FDA, EMA, or TGA. Vietnam has introduced expedited review pathways for products pre-approved by recognized SRAs and those addressing urgent public health needs. Recent reforms under Decree 07/2023/ND-CP and related MOH circulars have streamlined medical device registration timelines, introduced risk-based classification reviews, and improved e-submission capabilities, signaling a broader push toward regulatory modernization aligned with ASEAN harmonization commitments.

Public procurement of health products in Vietnam is primarily coordinated through the Ministry of Health, with procurement activities conducted at both the national and provincial levels. The MOH issues national bidding guidelines and centralized procurement lists, particularly for essential medicines and vaccines, through institutions such as the Vietnam Social Security (VSS) and designated national procurement agencies. Hospitals and provincial health departments conduct their own tendering processes in accordance with the Law on Bidding (Law No. 43/2013/QH13, as amended) and MOH Circular 15/2019/TT-BYT on pharmaceutical procurement. Public facilities are required to use approved price lists and preferred national tender outcomes, and procurement decisions are heavily influenced by price competition, creating pressure on margins for imported products. The government has progressively increased centralization of high-value procurement categories to improve efficiency and reduce costs.

The private healthcare sector in Vietnam is growing rapidly and represents a significant parallel procurement channel, with private hospitals, pharmacy chains, and diagnostic laboratories procuring directly from importers, distributors, and manufacturers outside the public tender framework. Donor-funded procurement channels are also present, particularly for vaccines, HIV/AIDS, tuberculosis, and malaria-related health commodities, with organizations such as UNICEF, the Global Fund, USAID, and Gavi playing active roles in funding and supply chain support. Vietnam has graduated from several donor programs as its economy has grown, gradually shifting toward self-financed procurement for previously donor-supported products, including vaccines through the Expanded Program on Immunization (EPI). The government maintains policies favoring locally manufactured health products in public tenders, offering preferential scoring to domestic producers under the Law on Bidding, which can create competitive challenges for fully imported products and incentivizes international manufacturers to explore local production partnerships or technology transfer arrangements.