Evaluation guidance rather than a binding standard
Japan’s Ministry of Health, Labour and Welfare (MHLW) issued notification 医薬機審発1007第2号 on 7 October 2026; it was made public on the ministry’s website on 9 October. The accompanying document, 歯科用骨補填材に係る評価について, sets out evaluation considerations for dental bone filling materials in marketing approval applications.
The notification states that the indicators are not standards established under legislation. The document also says it is not binding on the content of approval applications. It presents current scientific thinking to support appropriate and timely assessment, without establishing a general transition or remediation deadline.
Its principal material forms are calcium phosphate-based granules, blocks or hardening pastes, including products with porous structures or collagen. Other compositions or forms require a product-specific assessment of applicability and any additional evaluations. The scope concerns dental bone filling uses within the specified device categories, rather than all bone graft materials.
The proposed clinical use determines the question
Developers are asked to clarify whether the product is equivalent to an existing material used without planned dental implant placement, equivalent to one used in support of implant placement, or intended to address another unmet need. Similar chemical composition is only part of that analysis; structure, use method and claimed effects also matter.
The guidance distinguishes the oral environment from orthopaedic use because of resident oral microorganisms. In principle, simulated-use assessment should use jawbone models, such as dogs, under conditions representing the oral environment. Osteoconduction should be evaluated in a non-spontaneously healing defect model and in an environment simulating oral use. Resorbable materials require assessment of appropriate replacement by bone; non-resorbable materials require assessment of non-dissolution, non-degradation and effects on surrounding tissue.
For use anticipating dental implant placement, the regenerated bone must support osseointegration and withstand occlusal forces after placement of the superstructure. Human oral clinical evaluation is generally required, including improvement of masticatory function following superstructure placement. Evidence of bone ingrowth alone may therefore not answer the intended load-bearing clinical question.
Exceptions require a supported equivalence rationale
The document does not require clinical evaluation where structure, method of use, effects and other relevant characteristics are equivalent to an approved product and performance such as osteoconduction can be demonstrated non-clinically. Safety and effectiveness must still be evaluated through the equivalence analysis. Where another device is used in combination, combined-use evaluation is also needed.
The performance section provides qualified exceptions to the general human clinical expectation for implant-related use. One concerns changes such as shape modifications to an approved material where clinical performance can be evaluated without evaluating the influence of resident oral microorganisms. Another concerns a material equivalent to an approved filler already indicated for use with dental implants, where combined-use clinical performance can be evaluated without human clinical evaluation. The applicant must explain the validity of the proposed approach.
Neither exception follows automatically from a shape change or a shared material composition. The relevant conditions must be supported. Quality and safety characterisation of the final product, or specimens made under equivalent conditions, provides part of that foundation. Depending on form and characteristics, the document addresses crystal phase, porosity, mechanical properties and degradation, with additional hardening-time and heat-generation considerations for pastes.
The practical assessment is whether the proposed indication leaves clinical performance questions that non-clinical evidence cannot adequately answer. Oral exposure, implant combination use and the scope of the equivalence claim should be considered together before concluding that a human study is unnecessary.
Sources
- Primary official source歯科用骨補填材に係る評価について（医薬機審発1007第2号） (opens in a new tab)Ministry of Health, Labour and Welfare
- Supporting source新着通知 — 2026年10月9日掲載 (opens in a new tab)Ministry of Health, Labour and Welfare