The Taiwan Food and Drug Administration (TFDA) oversees drug registration, handling submissions, evaluations, approvals, and post-market surveillance to ensure safety, efficacy, and quality. It also facilitates accelerated pathways for priority drugs, such as orphan treatments, to speed up market access when necessary,... Read More
To register a new drug in Taiwan, companies must conduct preclinical and clinical trials, submit a New Drug Application (NDA) with relevant clinical and manufacturing data to the Taiwan Food and Drug Administration (TFDA), undergo a detailed review, possibly benefit from accelerated... Read More
Class I medical devices in Taiwan are considered low-risk products that require minimal regulatory control. They typically include items like bandages, surgical gloves, and dental materials. Manufacturers must register these devices with the TFDA, ensuring they meet basic safety and labeling requirements,... Read More
Medical device registration in Taiwan is governed primarily by the Medical Device Act, which outlines the regulatory framework for classification, approval, and post-market surveillance. Additional regulations include the Enforcement Rules of the Medical Device Act and relevant standards from the TFDA, ensuring... Read More
The TFDA regulates medical devices in Taiwan through a comprehensive framework that includes classification, registration, and post-market surveillance. It assesses safety and efficacy by reviewing clinical data and manufacturing practices. The TFDA also establishes guidelines for labeling and advertising, conducts facility inspections,... Read More
The TFDA medical device registration process typically takes 6 to 12 months, depending on the device’s risk classification and the completeness of the submitted documentation. Higher-risk devices may require longer review periods, especially if additional technical evaluations or clinical data are needed... Read More
The TFDA review process for medical device applications begins with document submission, including technical, safety, and efficacy data. The TFDA then conducts a thorough assessment based on device classification, followed by technical reviews, quality inspections, and risk evaluations. If all requirements are... Read More
The TFDA ensures Good Manufacturing Practice (GMP) compliance in medical device manufacturing by conducting regular facility inspections, reviewing manufacturing processes, and assessing quality control systems. Manufacturers must meet specific GMP standards, including documentation, equipment maintenance, and staff training. Non-compliance may lead to... Read More
TGMP (Taiwan Good Manufacturing Practice) requirements for Class III medical devices, which are high-risk, include strict controls over design, production, and quality management. Manufacturers must implement rigorous documentation, conduct comprehensive risk assessments, ensure traceability, and perform regular audits. They must also maintain... Read More
TGMP requirements for Class II medical devices in Taiwan include maintaining a quality management system, proper documentation of manufacturing processes, and adherence to risk management practices. Manufacturers must conduct regular inspections, ensure traceability of materials, perform product testing, and maintain records to... Read More