Taiwan

The Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW), is the primary regulatory authority responsible for the approval and post-market surveillance of health products in Taiwan, including pharmaceuticals, medical devices, in-vitro diagnostics, and digital health solutions. The principal governing legislation includes the Pharmaceutical Affairs Act (PAA) for drugs and biologics, and the Medical Devices Act (enacted in 2021) for devices and diagnostics. Products require a License (Registration Certificate) prior to commercialization, obtained through a structured review process that involves technical dossier evaluation, facility inspection, and, where applicable, clinical data assessment. Risk-based classification systems apply across product categories, with higher-risk products subject to more rigorous pre-market review pathways.

Applicants must appoint a local responsible agent or a Taiwan-registered company to submit and hold product licenses on behalf of foreign manufacturers. Dossiers are generally expected to conform to the Common Technical Document (CTD) format for pharmaceuticals and follow IMDRF-aligned standards for medical devices. Taiwan has progressively aligned its regulatory framework with international best practices, including participation in the Asia-Pacific Economic Cooperation (APEC) Medical Regulatory Harmonization initiative and mutual recognition efforts. Notable recent reforms include the full operationalization of the Medical Devices Act, which introduced a standalone regulatory framework separating devices from the broader Pharmaceutical Affairs Act, streamlined review pathways for innovative and breakthrough products, and expanded provisions for conditional approval and adaptive licensing to accelerate patient access to novel technologies.

Public procurement of health products in Taiwan is primarily coordinated through the National Health Insurance Administration (NHIA) under the MOHW, which administers the single-payer National Health Insurance (NHI) system covering over 99% of the population. Pharmaceutical reimbursement is governed by the NHI Drug Benefit and Reimbursement Schedule, with pricing determined through health technology assessment (HTA) processes and negotiations conducted by the NHIA. Medical devices and diagnostics may be reimbursed under NHI benefit schedules or procured by public hospitals through the Government Procurement Act framework, administered by the Public Construction Commission. Centralized tendering is used for high-volume or strategically important products, while individual public hospital systems retain some procurement autonomy for items outside central schedules.

Taiwan operates as a high-income economy with a well-developed private healthcare sector, meaning international donor-funded procurement channels such as UNICEF, the Global Fund, USAID, or Gavi are not applicable in the Taiwanese context. The private hospital and clinic sector represents a significant parallel procurement channel, with purchasing decisions influenced by NHI reimbursement status, clinical preference, and distributor relationships. Taiwan does not impose formal local manufacturing preference mandates as a general procurement rule; however, government industrial policy increasingly incentivizes domestic biomedical manufacturing through initiatives such as the Biomedical Industry Innovation Program and preferential support under the Taiwan Bio-Industry Organization ecosystem. Companies with local manufacturing or partnerships may benefit from enhanced engagement in public tenders and policy dialogues.