In Taiwan, TFDA medical device approval generally involves two main stages. The first stage is the Quality System Documentation (QSD) review, and the second stage is the product registration (license application) process.
During the QSD stage, foreign manufacturers must undergo a quality system documentation assessment to demonstrate that their manufacturing and quality management systems comply with TFDA requirements and relevant international standards. This includes preparing and submitting documents such as the quality manual, process controls, validation and verification reports, risk management files, change control procedures, and traceability and nonconforming product handling procedures.
After QSD approval, each medical device must go through TFDA product registration, also referred to as the “registration and market approval” stage. In this phase, TFDA reviews the safety and performance of the device, including technical documentation, clinical or literature evidence, risk analysis, labelling and IFU, test reports, and compliance with applicable standards. The depth of review and documentation requirements depend on the device class (Class I, II or III) and its risk level.
Our company has dedicated regulatory personnel who are familiar with TFDA QSD and product registration requirements. They are responsible for planning and managing QSD and registration timelines, coordinating and reviewing quality system and technical documents from foreign manufacturers, ensuring that labels, instructions for use and claims comply with Taiwan regulations, selecting appropriate application pathways according to device classification and risk, and responding to TFDA inquiries, deficiency letters and post-approval changes.
With this in-house expertise, we are able to support foreign medical device manufacturers in efficiently completing both QSD review and product registration for the Taiwan market, shortening time-to-market while ensuring full compliance with TFDA regulatory and quality requirements.
