In Japan, CDx devices are used in clinical trials to identify suitable patients for targeted therapies. These tests predict the response to a specific treatment based on genetic markers. The results help in selecting the patient cohort, enhancing the trial’s efficiency, and... Read More
The process for CDx approval in Japan involves submitting a dossier application to the Pharmaceuticals and Medical Devices Agency (PMDA). This includes detailed data on safety, efficacy, and quality. After review and if acceptable, Japan’s PMDA will grant registration approval, granting the... Read More
In Japan, Companion Diagnostics (CDx) are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA). They are classified as a CDx, IVD, or a program medical device. Before marketing, a CDx need to meet rigorous standards for safety, efficacy, and quality, and... Read More
During a GMP inspection, key focus areas include quality management systems, manufacturing processes, documentation, staff training and qualifications, equipment maintenance and calibration, design controls, risk management, and corrective/preventive actions. Inspectors assess compliance with regulatory requirements, ensuring product safety, efficacy, and adherence to... Read More
In Japan, the frequency of GMP inspections varies depending on the risk classification and type of medical device. Paper or on-site inspections typically occur during initial manufacturing site approval, after significant changes, or in response to quality-related issues. Regular paper or on-site... Read More
Japan’s Good Manufacturing Practices (GMP) ensure that medical device manufacturers adhere to established quality management systems and regulatory requirements, promoting product safety and efficacy. The GMP process involves inspections of manufacturing facilities, evaluating documentation, and assessing compliance with standards like Ministerial Ordinance... Read More
Japan has import restrictions for medical devices to ensure safety and efficacy. Imported devices must meet Japanese regulatory requirements, including pre-market certification or notification and GMP compliance. Collaborate with a licensed Marketing Authorization Holder for proper importation and ensure adherence to labeling... Read More
Medical device manufacturers should conduct internal audits regularly, at least annually, to ensure compliance with Japanese GMP and QMS standards. External audits by registered certification bodies or the PMDA occur every five years for QMS certification renewal. However, frequency may vary depending... Read More
Japanese labeling requirements for medical devices mandate displaying essential information in Japanese, including product name, MAH name and address, usage instructions, precautions, device classification, serial or lot number, manufacturing date or expiration, and storage conditions. Ensure compliance with Japan’s Pharmaceuticals and Medical... Read More
To prepare technical documentation for Japan’s PMDA, gather information on device design, manufacturing, preclinical and clinical data, and risk management. Translate documents into Japanese and create a detailed technical file. Consult the PMDA’s guidelines and engage a regulatory expert to ensure compliance... Read More