Medical Device and IVD Emergency Use Routes in Japan

Medical devices and IVDs are regulated by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. The MHLW requires medical devices and IVDs to be registered through an applicable route; Pre-market Approval, Pre-market Certification, and Pre-market Submission.

The MHLW has the authority to issue special authorizations for clinical use of unregistered devices and IVDs in some circumstances, and to-date has issued several policy announcements related to the current COVID-19 pandemic.

Regulations, guidance, and resources

As of this publication, the MHLW has released the following announcements:

  • Handling the review of Pre-market Approval for medical products due to the outbreak of COVID-19 infection (temporarily measures and policies)
    The MHLW will apply the Priority review system to medical products, including pharmaceuticals, medical devices, IVDs, and regenerative medicine products, contributing to diagnosis and treatment of patients with COVID-19.
  • Handling the review of Pre-market Approval for ventilators due to the outbreak of COVID-19 infection (temporarily measures and policies)
    This policy applies primarily to domestic manufacturers of non-medical industries, such as automotive manufacturers, who are involved in the manufacturing of ventilators. According to the policy, parts manufacturers will not be required to have an Establishment Registration.
    Companies involved in the assembly process must have an Establishment Registration; however, the registration and related procedures (Amendment PMA) will be expedited.
  • Consultation desk for companies developing ventilators.
    The MHLW set a new consultation desk for companies who are developing ventilators. The consultation desk provides consultation for reimbursement, stable supply, and device registration.

Device types and eligibility criteria

Most PPE is not regulated as a medical device in Japan and has free access to the Japanese market. In particular, surgical face masks, face shields, goggles, gowns, protective suits, and shoe covers, are not subject to regulatory control. Only examination gloves are regulated as a Class I medical device and require registration through the Pre-market Submission route.

The MHLW policies for COVID-19 related devices do not specify device types, but include all devices related to treatment and diagnosis of the disease.

All medical devices, including examination gloves and IVDs, are required to comply with standards and criteria set for each appropriate classification.

Pathway overview

All medical devices, including examination gloves and IVDs, require registration through standard applicable registration routes.

Medical products, including pharmaceuticals, medical devices, IVDs, and regenerative medicine, contributing to diagnosis and treatment of patient with COVID-19 will be given priority review.

Face masks, protective suits, and goggles for infection prevention are not considered medical devices in Japan. Therefore, foreign manufacturers can import and distribute such products without registration. However, hospitals and physicians may require conformance with applicable standards as their conditions of delivery, such as ISO 16602 or ASTM F2100-11.

Published on 15 April 2020.

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