Your Gateway to PMD Act Compliance for Medical Devices in Japan

Japan’s Pharmaceutical and Medical Device Act (PMD Act) sets stringent regulatory requirements for medical devices entering the Japanese market. Intertek’s deep expertise and comprehensive capabilities make us the ideal partner to guide you through this complex process, ensuring your devices meet Japan’s safety, performance, and quality standards.

Under the PMD Act, manufacturers must comply with detailed product testing, certification, and post-market surveillance requirements. Intertek provides end-to-end support, from initial design assessments to rigorous testing and documentation preparation. Our experts are well-versed in the nuances of Japan’s regulatory landscape and can help you navigate key processes such as registration, QMS compliance audits, and obtaining the necessary certifications for market approval.

With our global presence and local expertise, we ensure that your products align with the unique requirements of the Japanese market, minimizing delays and reducing time to market. Whether you’re a first-time entrant or expanding your portfolio in Japan, Intertek’s solutions provide the confidence you need to succeed.

Our expert medical device team in collaboration with our global market team will help streamline your compliance journey and unlock access to one of the world’s most advanced healthcare markets.

 

It is necessary to comply with the Pharmaceutical and Medical Device Act (PMD Act) when importing and selling medical devices from overseas into Japan. Download our free market access guide to ensure your products comply.

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** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.