FDA Taiwan Medical Device Registration
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.
Navigating the TFDA's Requirements
Regulatory Authority
Pure Global can assist with Taiwan medical device registration, ensuring TFDA approval to sell in the Taiwanese market.
Classification
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.
Key Requirements
To enter the Taiwanese market, foreign manufacturers must:
- Appoint a Taiwan Agent to facilitate interactions with the TFDA.
- Obtain ISO 13485 certification for all devices, excluding Class I non-sterile devices.
- Submit a quality system review application to obtain a QSD, followed by the device registration application.
Tailored Support for Market Entry
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.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Taiwan?
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.
How are medical devices classified in Taiwan?
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.
What are the key requirements for foreign manufacturers to market medical devices in Taiwan?
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.
Is ISO 13485 certification required for all medical devices in Taiwan?
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.
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