Following the issuance of the "Procedures for Changes to Raw Materials of Medical Devices", PMDA released supplementary FAQs and clarification points regarding the interpretation and application of the guidance.

Scope of Raw Material Changes

Question 1: What specifically is meant by "changes to raw materials that do not affect the essential quality, effectiveness, and safety"?

➜  Answer 1: For example, such changes to raw materials include the following cases:

• Changes made not with the intention of modifying the product specifications, but in response to discontinuation of raw material supply or for the use of alternative materials for cost reduction purposes.
• Minor changes in product specifications, such as changes/additions of colorants just for facilitating size identification, which do not affect the intended use or the therapeutic/diagnostic effect.

Applicability of Minor Change

Question 2: If a change falls under "changes to raw materials that do not affect the essential quality, effectiveness, and safety" but does not fall under "raw materials limited to low-risk", can it be considered that a change to a raw material with a different generic name from the current one and without prior use precedent would still be treated as a minor change?

➜  Answer 2: That is correct. However, the change should be implemented only after verifying internally that there are no quality, safety, or effectiveness issues, and the verification results should be retained so they can be provided upon request at a later date.

If the applicability is unclear, it is recommended to consider using the simplified consultation (簡易相談) for approved products or consult with the Registered Certification Body for certified products.

Raw Material Specification in Application

Question 3: What is the approach to specifying raw material information to be included in the specifications section (別紙規格) of the application form? In particular, when disclosure of information is restricted due to confidentiality reasons on the part of the raw material manufacturer, what is the minimum level of information required to adequately identify the materials?

➜  Answer 3: Table 2 provides examples of how raw materials can be identified by selecting and combining several of the specification items listed in Table 1.

Description of Omitted Raw Material Specifications

Question 4: When only the generic names are provided for raw materials, it is required to "include a statement in the raw materials section explaining the reason for omitting the material specifications". However, how should this reason be described?

➜  Answer 4: Please refer to the examples of the table below. (**) indicates a note added for components that fall under "medical devices with brief tissue contact", while (*) indicates an example of a note for other applicable components.

*: As the function of the component is simple, it is considered that equivalent performance can be achieved by alternative components made of different raw materials. Although the component comes into contact with blood or body fluids, the description of the material specification is omitted.

**: This component comes into contact with blood or body fluids for an extremely short duration during use of the device and corresponds to "medical devices with brief tissue contact" as defined in ISO 10993-1; therefore, the description of the material specification is omitted.

With the release of these FAQs, medical device manufacturers should review how raw material changes and specifications are documented to ensure alignment with Pharmaceuticals and Medical Devices Agency (PMDA) expectations.

Qualtech supports manufacturers in assessing change applicability, preparing documentation, and navigating PMDA consultation pathways.

Contact us to ensure your regulatory strategy remains compliant and well-positioned for submissions in Japan.

Reference

Q&A on Procedures for Changes to Raw Materials of Medical Devices