Your Gateway to the World's Second Largest Medical Device Market

Japan's position as the world’s second-largest medical device market, with a population of over 123 million and approximately 35% of medical devices imported, presents significant opportunities for global manufacturers. The country's advanced healthcare system and regulatory environment offer a fertile ground for high-quality medical devices.

Device Classification and Regulatory Pathways

Understanding Regulatory Classifications in Japan

Regulatory Authority

The Pharmaceuticals and Medical Device Agency (PMDA) is at the forefront of medical device registration in Japan, classifying products based on their risk level. The regulatory pathway varies from pre-market notifications for class I devices to more rigorous pre-market certification or approval processes for class II, III, and IV devices, emphasizing the need for compliance with Japan's stringent quality management system regulations.

Classification

Devices are categorized into classes I through IV, reflecting increasing risk levels. This classification dictates the regulatory requirements, from pre-market notification for class I devices to certification or approval processes for higher-class devices.

Key Requirements

Foreign manufacturers must navigate Japan’s regulatory landscape by:

  • Appointing a Japan-based Medical Device Handler (MDH) or Medical Device Authorized Representative (MDAR) if they lack a business presence in Japan. Pure Global has both licenses.
  • Ensuring compliance with Japan's Quality Management System (QMS) regulations.
  • Following the appropriate pre-market certification or approval pathway based on the device's classification.
How We Can Help

Tailored Support for Market Entry

Leverage our expertise to enter or expand your presence in the Japanese market:

  • Guidance on classifying your products and determining the appropriate regulatory pathway.

  • Assistance with compiling the necessary technical dossier for PMDA submission.

  • Representation as your Designated Marketing Authorization Holder (DMAH) , managing the registration process and ensuring post-market compliance.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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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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