Executive Summary/ Key Takeaways

• What is the classification system for medical devices under the PMD Act?
  Medical devices are classified into four categories based on their level of risk to the human body, ranging from Class I (low risk) to Class IV (high risk). This classification forms the basis for determining the required business licenses and regulatory procedures applicable to each product.
• What licenses are required to conduct a medical device business in Japan?
  Medical device businesses typically require several types of regulatory licenses, including (i) a Marketing Authorization Holder (MAH) license at the entity level, (ii) manufacturing registration for each manufacturing site, (iii) sales and leasing licenses at the business office level, and (iv) repair business licenses. The required licenses depend on the nature of the business and the class of devices involved.
• What are the product-level regulatory requirements for medical devices (notification, certification, and approval)?
  Depending on the device classification, medical devices are subject to one of three regulatory procedures: notification to the Pharmaceuticals and Medical Devices Agency (PMDA), certification by a registered certification body, or approval by the Minister of Health, Labour and Welfare. In general, devices with higher risk levels are subject to more rigorous regulatory review.
• What are “Specified Maintenance Control Medical Devices” and how do they differ from ordinary classification rules?
  Specified Maintenance Control Medical Devices are devices designated as requiring specialized maintenance, inspection, or repair due to the potential impact on diagnosis or treatment if not properly managed. Even devices classified as Class I or Class II may require sales or leasing licenses if they fall into this category.
• What regulatory issues should be examined in medical device M&A transactions or market entry?
  Companies should confirm at early stage the category of the target products, including their classification of the relevant medical devices and whether they qualify as Specified Maintenance Control Medical Devices, and then identify the necessary business licenses and product-level regulatory procedures. Early regulatory assessment is important to properly identify compliance obligations and transaction risks.