The Designated Marketing Authorization Holder (DMAH) in Japan is responsible for obtaining and maintaining marketing approval for medical device and In-Vitro Diagnostic (IVD) products. They act as a liaison between the manufacturer and the Japanese regulatory authorities, overseeing the device or IVD’s... Read More
To prepare for medical device audits in Japan, companies should ensure compliance with the Pharmaceutical and Medical Device Act (PMD Act), adhere to Good Manufacturing Practice (GMP) guidelines, maintain comprehensive documentation, establish quality management systems, conduct internal audits, train staff on quality... Read More
For a medical device audit in Japan, the required documents typically include the quality management system (QMS) documentation, device technical files, labeling and packaging information, risk management files and post-market surveillance reports. Additional documentation may be requested based on specific regulatory requirements... Read More
Common challenges during medical device audits in Japan include navigating the complex regulatory framework, ensuring compliance with stringent quality standards, language and cultural barriers, managing timelines, addressing labeling and packaging requirements, and staying updated on changing quality guidelines and interpretations. Effective preparation... Read More
Medical device GMP audits in Japan are conducted regularly to ensure compliance with safety and quality standards. The specific frequency may vary depending on factors such as risk classification and newness of the device. Generally, GMP audits are carried out periodically, with... Read More
In Japan, steps in a medical device audit include 1) Submitting necessary documents to the Pharmaceuticals and Medical Devices Agency (PMDA); 2) PMDA review and assessment; 3) In some cases, on-site inspection by the PMDA; 4) Evaluation of GMP manufacturing facilities and... Read More
Medical device certification in Japan follows a three-step process. First, manufacturers must obtain approval from the Pharmaceuticals and Medical Devices Agency (PMDA) by submitting the required documentation and conducting clinical trials, if necessary. Second, they apply for marketing certification. Lastly, post-market surveillance... Read More
Japan’s Quality Management System (QMS) for medical devices ensures stringent standards. It requires manufacturers to follow specific quality (GMP) regulations, including risk management and post-marketing surveillance. QMS helps to guarantee product safety, efficacy, and traceability. Adherence to Japan’s GMP requirements increases market... Read More
Drugs in China are regulated by the National Medical Products Administration (NMPA). The NMPA oversees drug registration, quality control, and clinical trials. It classifies drugs into different categories, enforces strict regulations, and monitors post-market surveillance. International pharmaceutical companies must comply with Chinese... Read More
The PMDA is Japan’s regulatory authority for pharmaceuticals and medical devices. Its role encompasses the evaluation and approval of drugs and medical devices, ensuring their safety, efficacy, and quality. The PMDA also conducts post-marketing surveillance, provides guidance to manufacturers, and collaborates with... Read More