Regulatory Background

Under Japan's medical device regulatory framework, certain post-approval changes may be processed through a minor change notification if they are deemed not to affect product quality, efficacy, or safety. The recent PMDA guidance clarifies how raw material changes should be evaluated within this minor change framework and outlines the conditions under which such changes may qualify for notification.

1. How to Fill in the Raw Materials Section of the Application Form

For the raw materials listed below, since changes are considered to have only a minimal impact on the quality, efficacy, and safety of the product, it is acceptable to indicate only the generic name of the material in the raw materials section of the approval/certification application. However, this provision does not apply to materials of biological origin, biodegradable materials, or materials used in implantable parts.

1. "Medical devices with brief tissue contact" as defined in ISO 10993-1, Biological evaluation of medical devices – Part 1
2. Raw materials used for securing other components or for sealing between components, where the contact area with blood, bodily fluids, or mucous membranes is clearly minimal. However, this does not apply to seals that come into direct contact with circulating blood or in cases where the continuous use of a single product is prolonged.
3. Coloring materials applied only to the surface of the medical device, where it is clear that they have no impact on the strength or other critical specifications of the product.
4. Materials used for auxiliary components or protective parts of mechanical mechanisms.

2. Raw Material Change Procedure under Minor Change application

Where a raw material change does not impact the quality, efficacy, or safety of the product, it is possible to proceed with the minor change application.

The types of changes that impact the quality, efficacy, or safety of the product, and therefore do not fall under the minor change notification procedure, are listed below.

1. Changes to raw materials that increase existing risks or create new risks related to the product's quality, efficacy, or safety.
2. Where the impact of the raw material changes on the quality, efficacy, and safety of the product cannot be sufficiently estimated.
3. Changes that clearly go beyond the intended use of the product or the scope of insurance coverage.
4. Changes whose impact on therapeutic or diagnostic effectiveness cannot be considered minor.
5. A raw material change was made to resolve a serious malfunction that occurred after market release.

3. Conditions for Accepting Raw Materials with Documented Clinical Use History

If the raw material meets all of the following conditions (①–⑥) and has already been used in medical devices that are approved or certified either in Japan or in foreign countries (referring to countries with regulatory systems recognized as harmonized with Japan and considered to be of a high standard, e.g., the United States), it can be considered to have a historical use.

When relying on medical devices approved or certified in foreign countries as prior use, this is limited to cases where there is sufficient clinical use experience.

1. The raw material is not derived from biological sources.
2. The change does not involve raw materials of implantable components/parts, or if it does, the general name of the raw material remains unchanged before and after the change.
3. The specifications of the post-change raw material, the type and amount of any additives, and other relevant characteristics are the same as those of the raw material used as a reference for prior use.
4. Regarding the level of contact with the body, the raw material has prior use in a medical device with the same ISO 10993-1 contact category, or in a category associated with higher risk.
5. Regarding the duration of contact with the body, the raw material has prior use in a device with the same ISO 10993-1 cumulative contact time category (e.g., temporary, short- or medium-term, long-term) or in a category with a higher risk.
6. For the medical device intended to be used as prior use reference, it should be confirmed that there are no recalls or reports of serious adverse events attributed to the raw material submitted to the regulatory authority.

Managing raw material changes in Japan requires careful assessment of regulatory classification, risk impact, and documentation strategy. Qualtech Consulting Corporation supports medical device companies in evaluating change pathways, preparing minor change notifications, and navigating PMDA review procedures.

Contact our regulatory specialists to ensure your raw material change strategy aligns with the latest PMDA requirements.

Reference

https://www.mhlw.go.jp/hourei/doc/tsuchi/T260202I0050.pdf