Taiwan

Health products in Taiwan are regulated by the Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW). The primary governing legislation includes the Pharmaceutical Affairs Act, the Medical Devices Act (enacted in May 2021 as a standalone law separating medical devices from pharmaceuticals for the first time), and supplementary regulations covering diagnostics, biologics, and digital health software. The general approval process requires product registration prior to market entry, with applicants submitting a dossier for review by TFDA technical committees. Medical devices are classified into three risk-based classes (Class I, II, and III), with higher-risk products requiring more rigorous conformity assessment, including clinical evidence and quality system certification. Pharmaceuticals follow a new drug application or generic drug application pathway, with TFDA conducting scientific review of safety, efficacy, and quality data.

Applicants must appoint a locally registered Taiwanese agent or subsidiary to act as the Marketing Authorization Holder (MAH), as foreign companies cannot hold registrations directly. Taiwan generally accepts dossiers compiled according to the Common Technical Document (CTD) format, and the country is a member of the International Council for Harmonisation (ICH), meaning ICH guidelines are broadly recognized. TFDA has implemented several reforms in recent years, including an expedited review pathway for innovative or breakthrough products (Fast Track and Priority Review designations), mutual recognition considerations with major regulatory agencies such as the US FDA, EMA, and Japan PMDA, and a progressive regulatory framework for Software as a Medical Device (SaMD) under the Medical Devices Act. Local clinical trial data may be required for certain novel products, though foreign clinical data is generally accepted when the study population is considered representative.

Public procurement of health products in Taiwan is primarily coordinated through the Ministry of Health and Welfare (MOHW) and its subordinate agencies, including the Health Promotion Administration and the Centers for Disease Control (CDC Taiwan). The National Health Insurance (NHI) program, administered by the National Health Insurance Administration (NHIA), is the dominant procurement and reimbursement mechanism, covering approximately 99% of the population. Products seeking public reimbursement must be listed on the National Health Insurance drug or device formulary, requiring a separate health technology assessment (HTA) and price negotiation process following regulatory approval. The NHIA sets reimbursement prices through negotiations that consider cost-effectiveness, budget impact, and reference pricing from comparator markets. Public hospitals, which represent a significant share of the healthcare system, procure listed products through centralized or institutional tendering processes aligned with NHI reimbursement schedules. The Government Procurement Act governs public tender procedures, emphasizing transparency, open competition, and value for money.

The private sector plays a meaningful role in Taiwan's healthcare market, particularly through private hospital networks, clinics, and retail pharmacy chains, which procure products independently of NHI formulary constraints for out-of-pocket or supplementary insurance segments. Taiwan is a high-income economy and does not typically rely on international donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi, which are more relevant in lower-income markets. However, Taiwan actively engages in international health diplomacy and may supply or procure products through bilateral agreements, particularly with countries that maintain formal or informal diplomatic ties. There are no broadly mandated local manufacturing preference policies comparable to those seen in some emerging markets, though the government has shown increasing interest in strengthening domestic biopharmaceutical and medical device manufacturing capacity through industrial policy initiatives, tax incentives, and public-private partnerships under frameworks such as the Biomedical Industry Development Strategy.