The MFDS reviews and approves over-the-counter (OTC) drugs by evaluating their safety, efficacy, and quality. Applicants must submit clinical data and manufacturing details. The MFDS classifies OTC drugs based on safety risks and usage. It also sets labeling and advertising requirements to... Read More
The MFDS monitors off-label drug use to ensure patient safety. While physicians may prescribe drugs off-label, the MFDS provides guidelines to minimize risks. It requires that any off-label use be supported by clinical evidence, and manufacturers cannot promote off-label uses. Post-market surveillance... Read More
The MFDS requires healthcare professionals, manufacturers, and importers to report adverse events within specific timeframes. Serious adverse events must be reported immediately or within 15 days, while non-serious cases are reported quarterly. Reports must include patient details, drug information, and event description.... Read More
Risk assessment plays a critical role in the TFDA medical device registration process by identifying potential hazards associated with the device and evaluating their impact on patient safety. Manufacturers must provide a comprehensive risk management report, demonstrating how risks are mitigated. This... Read More
For Class III medical device registration in Taiwan, required documentation includes a registration application form, product specifications, labeling information, and a Declaration of Conformity. Manufacturers must provide extensive clinical data, a risk management report, safety and efficacy studies, and compliance with relevant... Read More
For Class II medical device registration in Taiwan, required documentation includes a registration application form, product specifications, labeling information, and a Declaration of Conformity. Manufacturers must also submit clinical evaluation reports, safety and efficacy data, and evidence of compliance with relevant standards.... Read More
For Class I medical device registration in Taiwan, required documentation includes a registration application form, product specifications, labeling information, and evidence of compliance with applicable standards. Manufacturers must also provide quality management system documentation, such as ISO certification, and ensure that the... Read More
The process for submitting a medical device application to the TFDA involves several steps: first, prepare comprehensive documentation, including product specifications, clinical data, and manufacturing details. Next, submit the application online through the TFDA’s portal. The TFDA then reviews the submission, may... Read More
The TFDA classifies high-risk medical devices, typically categorized as Class III and Class IV, based on their potential impact on patient health and safety. These devices often require extensive clinical data, rigorous testing, and thorough risk assessments. The classification considers factors such... Read More
To determine the classification of your medical device in Taiwan, consult the TFDA’s classification guidelines, which outline criteria based on intended use and risk levels. Manufacturers can also review the Medical Device Act and its enforcement rules. If uncertain, seeking expert consultation... Read More