Taiwan, with its nearly 24 million population and a focus on biotechnology, pharmaceuticals, and medical devices sectors, presents a significant opportunity for the medical device industry. Driven by an aging population, the demand for high-end medical devices, of which approximately 60% are imported, is on the rise.
The Medical Devices Act (2021) governs Taiwan medical device registration requirements, emphasizing the importance of adherence to quality and safety standards.
Taiwan’s medical devices market will reach $3.19B by 2029 (5.59% CAGR), and the IVD market$1.39B by 2030 (8.4% CAGR). Growth is driven by tech advancements, rising healthcare spending (6.4% of GDP), and an aging population (17.56% 65+ in 2021, rising to 20% by 2025).
In Taiwan, medical devices are regulated by the Food and Drug Administration (TFDA), which is a division of the Ministry of Health and Welfare. Pure Global can assist with Taiwan medical device registration and local representation, ensuring TFDA approval to sell in the Taiwanese market.
Devices are categorized based on risk, with Class I being the lowest and Class III the highest. This classification dictates the regulatory requirements, including the necessity for a technical dossier for Class II and III devices, encompassing test reports and clinical data.
To enter the Taiwanese market, foreign manufacturers must:
Our services are designed to simplify your regulatory process in Taiwan:
Assistance with product classification and identification of the regulatory pathway.
Compilation of the technical dossier required for TFDA registration.
Acting as your Taiwan Agent, managing the registration with TFDA and ensuring compliance with post-market regulations.
The Taiwan Food and Drug Administration (TFDA) is the regulatory authority responsible for overseeing Taiwan medical device registration and compliance. The Medical Devices Act (2021) governs the regulatory framework.
Medical devices in Taiwan are classified based on their risk level: Class I (lowest risk), Class II, and Class III (highest risk). This classification determines the regulatory requirements for medical device Taiwan, including the necessity for a technical dossier for Class II and III devices, which must include test reports and clinical data.
Foreign manufacturers must appoint a Taiwan Agent to facilitate interactions with the TFDA. Additionally, they must obtain ISO 13485 certification for all devices, excluding Class I non-sterile devices. Under TFDA regulations, manufacturers must also submit a quality system review application to obtain a Quality System Documentation (QSD) certificate, followed by the device registration application.
ISO 13485 certification is required for all medical devices except for Class I non-sterile devices. This certification is part of the quality and safety standards emphasized by the Medical Devices Act (2021) and is necessary for the Taiwan FDA medical device registration process.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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