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Japanese Medical Device Regulatory Certification

Japanese Medical Device Regulatory Certification

Japanese Medical Device Regulatory Certification: A Comprehensive Guide

Japan has a highly advanced healthcare system, with cutting-edge medical technologies and innovative devices that are used extensively in its hospitals and clinics. To ensure the safety and efficacy of these medical devices, Japan has implemented a rigorous regulatory framework to certify devices before they can be marketed or sold within the country.

The Japanese Ministry of Health, Labour and Welfare (MHLW) is responsible for regulating medical devices in Japan. The MHLW is committed to protecting public health and ensuring that only safe and effective medical devices are available to patients. To achieve this goal, the MHLW has established a comprehensive regulatory framework that includes classification of devices, conformity assessment procedures, labeling requirements, and post-market surveillance.

Classification of Medical Devices in Japan

Medical devices in Japan are classified into three categories based on their level of risk: Class I, II, and III. The classification system is as follows:

  • Class I devices are considered low-risk and include simple devices such as gloves, bandages, and dental floss.

  • Class II devices are moderate-risk and include devices such as ultrasound machines, ECG machines, and surgical instruments.

  • Class III devices are high-risk and include complex devices such as pacemakers, implantable cardioverter-defibrillators (ICDs), and orthopedic implants.


    • The classification system is based on the level of risk associated with each device. Devices that pose a higher risk to patients are classified as Class III, while those that pose a lower risk are classified as Class I or II.

    Conformity Assessment Procedures

    Medical devices must undergo conformity assessment procedures before they can be marketed in Japan. The conformity assessment procedures involve testing and evaluation of the devices design, manufacturing process, and performance. There are several conformity assessment procedures available for medical devices in Japan, including:

  • Self-Declaration: This procedure involves the manufacturer making a declaration that their device conforms to the relevant standards and regulations.

  • Certification by a Notified Body: This procedure involves the manufacturer obtaining certification from an independent third-party organization known as a notified body. The notified body conducts an audit of the manufacturers quality management system (QMS) and verifies that the device meets the relevant standards and regulations.


    • Labeling Requirements

    Medical devices must meet labeling requirements before they can be marketed in Japan. Labeling requirements include:

  • Device Name: The device name must be clearly indicated on the label.

  • Device Description: A brief description of the devices function, purpose, and operating instructions must be included on the label.

  • Contraindications: Contraindications for use, such as allergies or other medical conditions that may affect the devices performance, must be listed on the label.

  • Warning and Precautions: Warning and precaution statements must be included on the label to alert healthcare professionals and patients of potential risks associated with the device.


    • Post-Market Surveillance

    Once a medical device is marketed in Japan, it must undergo post-market surveillance. Post-market surveillance involves monitoring the devices performance and safety over time. This includes:

  • Reportable Events: Manufacturers are required to report any adverse events or malfunctioning devices to the MHLW.

  • Device Performance Monitoring: Manufacturers must monitor the devices performance over time and submit reports to the MHLW.


    • Notified Bodies in Japan

    Notified bodies are independent third-party organizations that conduct conformity assessment procedures for medical devices. Notified bodies in Japan include:

  • TÜV Rheinland Japan K.K.

  • SGS Japan KK

  • Intertek Japan Co., Ltd.


    • These notified bodies have been designated by the MHLW to perform conformity assessment procedures for medical devices.

    QA Section

    Q: What are the requirements for labeling medical devices in Japan?
    A: Medical devices must meet labeling requirements, including device name, description, contraindications, and warning and precaution statements.

    Q: How do I obtain certification from a notified body in Japan?
    A: To obtain certification from a notified body, you will need to submit an application, provide documentation of your quality management system (QMS), and pay the required fees. The notified body will then conduct an audit of your QMS and verify that your device meets the relevant standards and regulations.

    Q: What is post-market surveillance?
    A: Post-market surveillance involves monitoring the performance and safety of medical devices over time. This includes reporting adverse events or malfunctioning devices to the MHLW.

    Q: How do I classify my medical device in Japan?
    A: The classification system is based on the level of risk associated with each device. Devices that pose a higher risk are classified as Class III, while those that pose a lower risk are classified as Class I or II.

    Q: Can I self-certify my device for sale in Japan?
    A: Yes, you can self-declare your devices conformity to the relevant standards and regulations. However, this procedure is only available for Class I devices.

    Q: What is the difference between a notified body and a certification body?
    A: A notified body is an independent third-party organization that has been designated by the MHLW to perform conformity assessment procedures. A certification body is an organization that provides certification services to manufacturers, but may not be a notified body.

    Q: How do I ensure compliance with Japanese regulatory requirements?
    A: To ensure compliance with Japanese regulatory requirements, you should:

  • Familiarize yourself with the relevant regulations and standards

  • Implement a quality management system (QMS) that meets the requirements of ISO 13485

  • Obtain certification from a notified body for Class II or III devices

  • Submit reports to the MHLW as required


    • Note: The information provided in this article is intended for general guidance only. Manufacturers should consult with a qualified regulatory expert or attorney to ensure compliance with Japanese regulations and standards.

    This comprehensive guide has covered the key aspects of Japanese medical device regulatory certification, including classification, conformity assessment procedures, labeling requirements, post-market surveillance, and notified bodies. By understanding these requirements, manufacturers can ensure that their devices meet the necessary standards and regulations for sale in Japan.

    Japans regulatory framework is complex and requires a thorough understanding of its unique requirements and standards. Manufacturers should be aware that non-compliance with Japanese regulations may result in fines, penalties, or even product recall.

    By following this guide, manufacturers can navigate the complexities of Japanese medical device regulatory certification and ensure that their devices meet the necessary standards for sale in Japan.

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