Taiwan

The Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW), is the primary regulatory authority responsible for overseeing the safety, efficacy, and quality of health products in Taiwan, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. The principal governing legislation includes the Pharmaceutical Affairs Act (PAA), the Medical Devices Act (enacted in 2021, separating medical devices from the PAA for the first time), and associated subordinate regulations. The general approval process requires manufacturers or their local agents to submit a product registration application to the TFDA, which conducts technical review of submitted dossiers before granting a market authorization license. Risk-based classification frameworks are applied across product categories, with higher-risk products subject to more stringent pre-market review requirements.

For pharmaceutical submissions, Taiwan accepts dossiers prepared in accordance with the International Council for Harmonisation (ICH) Common Technical Document (CTD) format, and the TFDA participates in mutual recognition and reliance arrangements with select international regulatory partners, including the US FDA and EMA, to facilitate expedited review pathways for products with established foreign approvals. Medical devices follow a classification system (Class I, II, III) aligned broadly with international frameworks, and higher-class devices require full technical documentation and clinical evidence. A locally registered agent or representative (a Taiwan-based entity) is mandatory for all foreign applicants seeking product registration. Notable recent reforms include the implementation of the standalone Medical Devices Act in 2021, expanded digital health and software as a medical device (SaMD) guidance, and the introduction of an adaptive pathway for innovative or urgently needed products, allowing conditional approvals supported by post-market surveillance commitments.

Public procurement of health products in Taiwan is centrally coordinated through the Ministry of Health and Welfare (MOHW) and its affiliated agencies, with the National Health Insurance Administration (NHIA) playing a dominant role in determining which products are reimbursed under Taiwan's single-payer National Health Insurance (NHI) system, established in 1995. The NHI covers the vast majority of the population and represents the primary channel through which health products reach patients in the public sector. Pharmaceutical and device reimbursement listing is governed by the NHIA's drug benefit and reimbursement scheme, which involves a formal health technology assessment (HTA) process, price negotiations, and periodic price reviews. Government procurement of health commodities outside the NHI framework, such as for public health programs or emergency stockpiling, is conducted in accordance with the Government Procurement Act administered by the Public Construction Commission, with the MOHW and its Centers for Disease Control (CDC) acting as key purchasing entities for vaccines and communicable disease-related products.

Taiwan operates a mature, high-income healthcare market with a relatively limited role for international donor-funded procurement channels such as UNICEF, the Global Fund, USAID, or Gavi, as it does not qualify as a recipient country for most such programs. The private sector constitutes a significant portion of healthcare delivery, with private hospitals, clinics, and pharmacies procuring products independently through distributors and local agents, often subject to NHI reimbursement pricing as a reference benchmark. Taiwan has developed a growing domestic medical device and pharmaceutical manufacturing industry, and while there is no formal mandatory local manufacturing preference policy, government initiatives under the MOHW and the Ministry of Economic Affairs (MOEA) actively encourage domestic production and investment in biotechnology and medical innovation, including preferential support for locally developed products in public procurement tender evaluations where applicable.