Phase II and Phase III clinical trials in South Korea must meet guidelines set by the Ministry of Food and Drug Safety (MFDS). Sponsors must submit detailed trial protocols, ensuring safety, efficacy, and ethical compliance. Good Clinical Practice (GCP) standards apply, with... Read More
The TFDA ensures long-term safety of medical devices through post-market surveillance, adverse event reporting, and periodic safety updates. It conducts inspections, monitors device performance, and requires manufacturers to submit safety and performance data. The TFDA may also issue recalls or safety alerts... Read More
In Taiwan, medical devices must meet TFDA’s Good Manufacturing Practice (GMP) standards, which ensure consistent quality. Manufacturers are required to establish robust quality control systems, covering design, production, labeling, and packaging. Regular inspections, testing, and documentation are mandatory to verify compliance, along... Read More
After approval, the TFDA requires manufacturers to submit device modification applications for significant changes affecting safety, efficacy, or intended use. Minor changes may only require notification. The TFDA reviews the impact of these modifications, and depending on their significance, may require additional... Read More
In Taiwan, the Taiwan Food and Drug Administration (TFDA) ensures the safety of high-risk medical devices by conducting rigorous pre-market reviews, product registration, and quality inspections. It also performs post-market surveillance, enforces regulatory compliance, and monitors adverse event reports to safeguard public... Read More
The Taiwan Food and Drug Administration (TFDA) regulates the distribution of medical devices by requiring pre-market approval, product registration, and classification based on risk levels. It oversees importation, distribution, and labeling compliance, conducts inspections, and monitors post-market safety through adverse event reporting... Read More
Penalties for non-compliance with TFDA post-market requirements in Taiwan include fines, product recalls, suspension or revocation of product licenses, and business operation restrictions. Severe violations can lead to criminal charges, with potential imprisonment and substantial fines, depending on the severity and risk... Read More
Periodic safety updates play a crucial role in TFDA post-market surveillance by providing ongoing data on a medical device’s safety and effectiveness. Manufacturers submit these reports to the TFDA, detailing adverse events, performance trends, and risk assessments, allowing the TFDA to monitor... Read More
The TFDA handles medical device recalls by categorizing them based on the risk to public health. It requires manufacturers or distributors to notify affected parties, implement corrective actions, and submit recall plans. The TFDA monitors the recall process, ensures compliance, and may... Read More
In Taiwan, medical device manufacturers, importers, and healthcare providers must report adverse events to the TFDA within specific timeframes. Serious incidents require reporting within 10 days, while less severe events must be reported within 30 days. Reports must include detailed information on... Read More