Japan: FAQs and Key Points on Biological Raw Materials – June/July 2026

• 2026-07-27 02:48:38

The PMDA has issued a Q&A document providing practical guidance on the implementation of the Standards for Biological Raw Materials to ensure the quality and safety of pharmaceuticals, medical devices, and related products. The updated guidance addresses topics such as ensuring the reliability of donor screening and testing, the evaluation of prion clearance values, and considerations related to BSE risk status designations, thereby clarifying the latest operational approach to the Standards for Biological Raw Materials.

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Japan: Frequently Asked Questions and Tips for Identifying Raw Materials in the Application Form – February/March 2026

• 2026-04-01 03:38:31

Following the latest release of the "Procedures for Changes to Raw Materials of Medical Devices", PMDA has provided a side notice with Frequently Asked Questions (FAQs) and concepts for specifying raw materials in applications. In this article, we have extracted several questions that foreign manufacturers may need to pay attention to.

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Japan: Procedures for Changes to Raw materials of Medical Devices – January/February 2026

• 2026-02-25 03:48:52

PMDA recently released the revision for managing changes to raw materials used in medical devices. The revision clarifies the scope of minor change notifications that do not impact safety or performance and consolidates the criteria for determining applicability in low-risk cases or where sufficient prior usage experience exists.

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