日本PMDA：器械路径与审评时限

What is Japan's PMDA? Since 2004, it has reviewed medicines and medical devices, and tracked their safety after they launch. But it does not grant the approval. PMDA publishes its review clock, and how it performs. In fiscal year 2025, its scorecard covered 38 new medical devices approved on standard review. 34 of them were approved within its target: 14 months from application. The route depends on the class. Class I is a notification to PMDA. Class II and III devices with certification standards go to a registered certification body. The rest, and every Class IV device, need ministry approval after PMDA review. And one point that often gets mixed up. PMDA does the scientific review and the safety monitoring. The approval decision belongs to the Ministry of Health, Labour and Welfare. Start with three things. One: confirm your device class and its route. Two: appoint a marketing authorization holder based in Japan. Three: prepare the application forms in Japanese, not English. Pick the route before the dossier. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.