The Japanese Quality Management System (QMS) standard, known as Ministerial Ordinance No. 169, is a set of regulatory requirements for medical device manufacturers. It encompasses quality assurance, risk management, design controls, and production controls, ensuring product safety and efficacy. The QMS standard... Read More
Clinical trials may be required for medical device approval in Japan, depending on the device’s risk classification and novelty. Higher risk devices, such as Class III and IV, often necessitate local clinical trials in Japan to demonstrate safety and efficacy. Lower risk... Read More
Registering a medical device in Japan involves first classifying the device based on risk, preparing a dossier and technical file, and doing applications for FMR and QMS. Work with a Marketing Authorization Holder (MAH) to submit required documentation to the PMDA. Upon... Read More
To prepare for a Japanese GMP (Good Manufacturing Practice) inspection, ensure strict compliance with Japan’s Pharmaceuticals and Medical Devices Act. Develop thorough documentation, establish quality management systems, conduct internal audits, provide employee training, and proactively address potential issues. Engage a regulatory consultant... Read More
Yes, you can expedite the medical device approval process in Japan through the Pharmaceutical and Medical Devices Agency’s (PMDA) priority review system. This fast-track approach, called Sakigake, prioritizes innovative, high-impact devices addressing unmet medical needs, significantly reducing the standard review timeline, and... Read More
The primary regulatory bodies for medical devices in Japan are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour, and Welfare (MHLW). The PMDA evaluates and approves medical devices, while the MHLW establishes and enforces regulations, standards, and... Read More
To ensure Asian medical device suppliers meet international standards, perform comprehensive supplier audits, verify certifications (e.g., ISO 13485), and assess their quality management systems. Regularly monitor and assess supplier performance, foster open communication, and provide clear expectations. Collaborate with suppliers to address... Read More
Regulatory compliance requirements for imported medical devices in Asia vary by country but generally include registration, product classification, technical documentation, clinical data, quality management system certification, and labeling requirements. Engaging local regulatory experts and understanding each country’s specific guidelines will help ensure... Read More
To mitigate supply chain risks in Asian medical device procurement, establish strong relationships with reputable suppliers, diversify your sourcing, conduct thorough supplier audits, and implement robust quality control measures. Additionally, develop contingency plans for potential disruptions and monitor regional geopolitical, economic, and... Read More
The key quality assurance factors to consider when sourcing in Asia include selecting reliable suppliers with good manufacturing practices (GMP), conducting thorough inspections and audits, monitoring the production process, and ensuring compliance with relevant regulations and standards. Effective communication and strong relationships... Read More