The validity period for Medical Device Registration in Taiwan is typically five years. After this, manufacturers or authorized representatives must apply for renewal to maintain the registration’s validity. It is essential to comply with the renewal process and submit the required documentation... Read More
Yes, there are fees associated with Medical Device Registration in Taiwan. The specific fees may vary depending on the type of medical device and the regulatory requirements. It is advisable to consult the Taiwan Food and Drug Administration (TFDA) or a professional... Read More
Medical Device Registration in Taiwan is the process through which medical devices are evaluated and approved by the Taiwan Food and Drug Administration (TFDA) for market entry. It involves submitting comprehensive documentation on safety, efficacy, and quality, ensuring compliance with regulatory requirements.... Read More
The Taiwan Food and Drug Administration (TFDA) is responsible for medical device registration in Taiwan. They oversee the evaluation, approval, and regulation of medical devices to ensure their safety and effectiveness. Manufacturers and importers must comply with TFDA’s requirements and submit the... Read More
The required documentation for medical device registration in Korea typically includes product information, clinical trial data (if applicable), labeling and packaging details, manufacturing and quality control information, safety and performance test reports, and a valid Certificate of Free Sale. Additional documents may... Read More
The classification system for medical devices in Korea is based on risk levels. It categorizes devices into four classes: Class I (low risk), Class II (moderate risk), Class III (high risk), and Class IV (highest risk). The classification determines the regulatory requirements... Read More
The requirements for Medical Device Registration in Taiwan include submitting the application form, labeling and instruction manuals, proof of Good Manufacturing Practice (GMP) compliance, device specifications, clinical evaluation data, and a product testing report. The application must be filed with the Taiwan... Read More
The registration requirements for medical devices in Korea include submission of application documents, clinical trial data (if applicable), labeling information, quality management system certification, and post-market surveillance plan. The process involves a review by the Ministry of Food and Drug Safety to... Read More
The CDx market in Japan is projected to grow significantly due to the rising prevalence of cancer, advancements in genomics, and increased acceptance of personalized medicine. The demand for predictive, precise treatments, and the country’s robust healthcare infrastructure further support this expected... Read More
Some leading companies in the Companion Diagnostics (CDx) sector in Japan include Roche Diagnostics, Myriad Genetics, Foundation Medicine, and Sysmex Corporation. These companies play a significant role in advancing personalized medicine in Japan, particularly through the development and provision of innovative CDx... Read More