This video walks you through the full medical device registration process in Japan, from classification and QMS compliance to appointing a DMAH and submitting your application to PMDA. Learn how to navigate one of the world’s most regulated yet opportunity-rich markets.
This video provides a practical guide to registering a medical device in Japan through the Pharmaceutical and Medical Device Agency (PMDA), the country’s primary regulatory body. As the world’s second-largest medical device market, valued at $37.97 billion and projected to grow at over 5% annually, Japan presents massive opportunities for global manufacturers. But navigating its complex regulatory framework, classification rules, and local representation requirements demands expert knowledge and strategic planning.
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Japan’s aging population (nearly 30% aged 65+), high healthcare spending (over 10% of GDP), and heavy reliance on imports (60% of medical devices) make it one of the most attractive yet regulated markets globally. Whether you're marketing Class I software or a high-risk implantable, you’ll need to follow the correct regulatory pathway defined by Japan’s risk-based classification system (Class I, II, III, or IV) each with its own documentation, testing, and approval requirements. Class I devices may only require notification, while Classes II–IV involve more stringent review through certification or approval by PMDA and the Ministry of Health, Labour and Welfare (MHLW).
For foreign manufacturers, one of the most critical steps is appointing a Japan-based Designated Marketing Authorization Holder (DMAH), a mandatory local entity that manages your registration and serves as your legal liaison with Japanese authorities. The DMAH is also responsible for post-market obligations, including adverse event reporting, recalls, and compliance with local Quality Management System (QMS) requirements.
Need help navigating PMDA?
Contact Pure Global for end-to-end support with your Japan medical device registration. Our local team ensures you meet every regulatory obligation while accelerating time to market in Asia’s most advanced healthcare economy. Learn more about PMDA Japan Medical Device Registration.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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