Sep 21, 2022

Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become familiar with these changes to maintain compliance and ensure market access. All links below are in Japanese.

MHLW Order No. 128, Partial Revision of the Regulation for Enforcement of the PMD Act

Japan’s Ministry of Health, Labour and Welfare (MHLW) has released Order No. 128, which is intended to revise portions of the Regulation for Enforcement of the Pharmaceuticals and Medical Devices Act (MHLW Order No. 1 of February 1, 1961). The order will become effective on December 1, 2022.

The revisions include changes to the special provisions for labeling of medical devices set out in Article 224 of the Pharmaceuticals and Medical Devices Act (PMD Act). Specifically, the revised provision offers updated methods for displaying codes and precautions prescribed in Article 63-2(1) and Article 68-2 of the PMD Act, respectively, for medical device programs provided through telecommunication lines.

Revised Implementation Guideline for Bar Code Labeling on Devices

The MHLW has released PSEHB/PSD Notification No.  0913-2 to revise the Implementation Guideline for Bar Code Labeling on Containers of Medical Devices, Etc. The guidance is for bar code labeling of medical devices, in-vitro diagnostics, and consumable materials that are used repeatedly for medical purposes exclusively at medical institutions. The revised guideline specifies exemptions and exclusions, data to be displayed per device type, how to display expiration dates, barcodes to be used and database registration.

Emergo by UL will continue to post updates to MHLW guidance as it becomes available.

Learn more about Japanese medical device regulations from Emergo by UL:  

  • Japan Medical Device Nomenclature (JMDN) and medical device classification consulting
  • Whitepaper: Japan’s PMD Act
  • Whitepaper: PMDA Pre-Submission consultation for medical devices

Author

  • Kathryn Burke's picture
    Kathryn Burke

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