Jun 16, 2022

Japan’s medical device regulators have updated processes and procedures that manufacturers and suppliers must comply with in order to obtain Japanese market access. These latest changes include revisions to the Pharmaceuticals and Medical Devices (PMD) Act and the online submission process. All links below are in Japanese.

Act on Partial Revision of the Pharmaceuticals and Medical Devices Act

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published the Act on Partial Revision of the Pharmaceuticals and Medical Devices Act (Act No. 47, dated May 20, 2022).

The revised guidelines introduce an emergency approval system and establish an electronic prescription system. Manufacturers should take note that Act No. 47 adds a new Article 23-2-6-2, which stipulates medical devices and in vitro diagnostic (IVD) devices meeting certain criteria may receive approval for a period of not more than two years.

Such devices must meet conditions including:

  • They must be urgently needed to prevent the spread of diseases and other health hazards that may have a significant impact on the lives and health of the people, and there is no appropriate method other than the use of such medical devices or IVDs
  • It is presumed to have the effect or performance related to the application
  • It isn’t presumed that they have no value in use as medical devices because they have a significantly harmful effect compared to the performance of the application

Provisions are outlined in Act No. 47 and explanations are included in Pharmaceutical Safety and Environmental Health Bureau (PSEHB) Notification No. 0520-2.

MHLW abolishes notification prioritizing review of COVID-19 devices

The MHLW abolished PSEHB/MDED Notification No. 0512-1 (dated May 12, 2020), which was intended to define the procedures for reviewing pharmaceuticals, medical devices, IVD devices and regenerative medicine products for the novel coronavirus. This was done following the enforcement of the Act on Partial Revision of the Pharmaceuticals and Medical Devices Act (Act No. 47), which introduces a new emergency approval system. However, it was noted that priority will continue to be given to reviews of products used to diagnose or treat the novel coronavirus.

Details are included in PSEHB/MDED Notification No. 0520-7.

Updates on the online submission of notifications

After renovating its Gateway System used for the online submission of application forms, the MHLW updated the process for the online submission of notifications, such as those related to the approval or permission of various products, including medical devices and IVDs. Notably, applications and notifications that were not subject to online submission requirements previously will start to be accepted. Forms subject to online submission starting July 1, 2022 are identified in PSEHB/MDED Notification No. 0519-1.

Emergo by UL will post updates to Japan’s medical device regulations as they become available.

Learn more about complying with Japan’s medical device regulations from Emergo by UL:

  • Japan PMDA registration and approval consulting
  • Japan MHLW Ordinance 169 quality system compliance support
  • Japan's Pharmaceutical and Medical Devices Act (PMD Act) white paper

Author

  • Kathryn Burke's picture
    Kathryn Burke

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