Taiwan

The primary regulatory authority for health products in Taiwan is the Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW). The TFDA is responsible for the registration, approval, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and digital health products. The principal governing legislation includes the Pharmaceutical Affairs Act (PAA), the Medical Devices Act (enacted 2021, fully effective 2024), and associated MOHW administrative regulations. All health products must undergo a formal product registration process before market entry, which typically involves a technical review of safety, efficacy, and quality data submitted through a licensed local agent or representative. Risk-based classification systems are applied across product categories, with higher-risk products subject to more rigorous pre-market review pathways.

Applicants are required to appoint a locally registered Medical Device License Holder (MDLH) or pharmaceutical manufacturer or agent with a valid establishment license in Taiwan. Dossier submissions generally follow the Common Technical Document (CTD) format for pharmaceuticals, while medical device submissions align with IMDRF guidance frameworks and TFDA-specific technical guidelines. Taiwan has progressively harmonized its regulatory framework with international standards, including recognition of certain approvals from major reference authorities such as the US FDA, EMA, PMDA (Japan), and Health Canada, which can support expedited review pathways for qualified products. Notable recent reforms include the full implementation of the Medical Devices Act separating device regulation from the PAA, the introduction of a Software as a Medical Device (SaMD) regulatory pathway, and ongoing expansion of the Priority Review designation program for innovative and urgent medical need products.

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 approximately 99% of the population. Pharmaceutical and medical technology products seeking NHI reimbursement must undergo a Health Technology Assessment (HTA) process managed by the NHIA, followed by pricing negotiations and listing on the NHI Drug Benefit Schedule or medical device reimbursement lists. The NHIA conducts periodic price adjustments and reference pricing reviews, and hospital procurement for NHI-reimbursed products is largely executed through individual hospital tenders or group purchasing arrangements coordinated at the institutional or regional level. Major public hospitals, including those affiliated with Veterans Affairs, the National Taiwan University Hospital system, and other government-linked institutions, represent key procurement channels and typically follow Government Procurement Act (GPA) procedures for product sourcing.

The private healthcare sector in Taiwan is substantial, encompassing private hospitals, clinics, and retail pharmacies, which procure health products through distributors, direct supplier agreements, and group purchasing organizations outside the NHI framework. Taiwan does not rely on major multilateral donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi, as it is a high-income economy with a self-funded universal health coverage system. However, Taiwan actively participates in international health cooperation initiatives, including bilateral partnerships in the Asia-Pacific region. There are no broad local manufacturing preference mandates in procurement, though the government has introduced strategic policies under its biomedical industry development agenda to incentivize domestic production of critical health products, including vaccines and active pharmaceutical ingredients, particularly following supply chain resilience reviews conducted during and after the COVID-19 pandemic.