1. Transition Schedule

Grace Period: Until February 24th, 2026

• Medical devices manufactured and marketed on or after February 25, 2026 must comply with the new standard (JIS T 0601-1-2:2023).
• Medical devices manufactured and marketed before February 24, 2026 must comply with either the old standard (JIS T 0601-1-2:2018) or the new standard (JIS T 0601-1-2:2023).

2. Confirmation of Compliance with Basic Requirements Standards Article 13, Paragraphs 5 and 6 for Medical Devices

• For devices newly submitted for approval on or after February 25, 2026:
  Documentation demonstrating conformity with the new standard (JIS T 0601-1-2:2023) must be submitted at the time of application.
• Medical devices manufactured and marketed before February 24, 2026:
  Approval under the old standard remains valid during the transition period. After the transition period, continued marketing under the old standard (JIS T 0601-1-2:2018) is still permitted. However, risk management related to electromagnetic compatibility must be conducted in accordance with JIS T 14971, and it must be determined whether additional or re-evaluation of requirements and testing under the new standard (JIS T 0601-1-2:2023) is necessary.

3. Documentation and Retention of Work-Related Activities

Records and assessment reports concerning standard compliance shall be appropriately retained. Upon request for investigation, relevant documentation shall be promptly submitted and adequately explained.

4. Examples of Internationally Recognized Standards Concerning Electromagnetic Compatibility (EMC)

The latest edition of these standards should be used. If products are following these standards, the explanation of the appropriateness of the standards may be omitted.

• Implantable device
  ISO 14117:2019, Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
• In vitro diagnostic device (IVD device)
  JIS C61326-2-6:2023, 計測用，制御用及び試験室用の電気装置－電磁両立性（EMC）要求事項－ 第２－６部：個別要求事項－体外診断用医療機器
  IEC 61326-2-6:2020, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

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