Thailand

Health products in Thailand are regulated by the Food and Drug Administration (FDA) under the Ministry of Public Health (MOPH). The Thai FDA operates under a suite of product-specific legislation, including the Drug Act B.E. 2510 (1967) and its amendments for pharmaceuticals, the Medical Devices Act B.E. 2562 (2019) for medical devices and in vitro diagnostics, and the Thai FDA's evolving framework for digital health and software as a medical device (SaMD). All health products intended for the Thai market must undergo a pre-market registration process administered by the Thai FDA, which evaluates safety, efficacy, and quality through defined review pathways that vary by product risk classification. Pharmaceuticals are classified as modern drugs or traditional medicines, while medical devices follow a four-tier risk classification system (Class 1 through Class 4), with higher-risk products requiring more rigorous conformity assessment and clinical evidence.

Foreign manufacturers seeking market authorization in Thailand must appoint a locally registered importer or licensee who acts as the authorized representative and assumes regulatory responsibility within the country. Submission dossiers for pharmaceuticals generally follow the ASEAN Common Technical Dossier (ACTD) format, which is aligned with but distinct from the ICH CTD, reflecting Thailand's participation in the ASEAN Pharmaceutical Product Working Group (PPWG). For medical devices, technical files must include ISO 13485 certification or equivalent quality management system evidence, along with conformity assessments from recognized bodies. Thailand has progressively pursued regulatory harmonization through ASEAN frameworks, including the ASEAN Medical Device Directive (AMDD), and has introduced reforms such as expedited review pathways for products that have received approval from stringent regulatory authorities (SRAs) such as the US FDA, EMA, or PMDA, potentially reducing review timelines for priority products. Digital health products and SaMD are subject to emerging guidelines, and applicants are advised to engage in pre-submission consultations with the Thai FDA to clarify classification and pathway requirements.

Public procurement of health products in Thailand is primarily coordinated through the Ministry of Public Health (MOPH), which oversees a network of public hospitals, district health offices, and health-promoting hospitals across 77 provinces. The Government Pharmaceutical Organization (GPO), a state enterprise under the MOPH, plays a central role in the domestic production and procurement of essential medicines, vaccines, and some medical supplies, and has the authority to invoke compulsory licensing for certain essential pharmaceuticals. National-level procurement is governed by the Public Procurement and Supplies Administration Act B.E. 2560 (2017), administered by the Comptroller General's Department under the Ministry of Finance. The National Health Security Office (NHSO) manages the Universal Coverage Scheme (UCS), one of Thailand's three main public health insurance schemes, and procures health products at scale through centralized contracting mechanisms, often leveraging the GPO and competitive tendering processes. Products must typically be registered with the Thai FDA before they are eligible for inclusion on national reimbursement lists or formularies, such as the National List of Essential Medicines (NLEM).

The private sector represents a significant and growing channel for health products in Thailand, encompassing private hospitals, clinic chains, retail pharmacies, and a robust medical tourism industry concentrated in Bangkok and major urban centers. Private procurement is decentralized and driven by individual hospital and distributor purchasing decisions, with international and premium-branded products often commanding a strong presence. Thailand receives limited donor-funded procurement relative to lower-income countries in the region, though organizations such as UNICEF and the Global Fund have historically supported HIV, tuberculosis, and malaria commodity procurement in collaboration with the MOPH. Thailand graduated from Gavi support and is largely self-financing for its national immunization program, reflecting its upper-middle-income status. The government maintains a policy preference for locally manufactured and GPO-produced products in public tenders, and there are ongoing incentives under the Thailand 4.0 and Bio-Circular-Green (BCG) economic strategies to develop domestic medical device and pharmaceutical manufacturing capacity, which may influence future procurement and localization requirements.