The "review guidelines" are specified by MHLW and describe the major technical requirements and/or the acceptance criteria, etc. necessary to evaluate the safety and efficacy of medical devices, although no specific performance limits are determined for each technical requirement. The guidelines contribute to more efficient PMDA reviews of medical devices.

【Contents of review guideline】

1. Intended use / indications

The purpose is specified for each review guideline.

2. Scope

Applicable medical devices are defined by Japanese Medical Device Nomenclature (JMDN), and the intended use and indications of the medical devices are also specified in principle.

3. Technical guideline

The technical requirements for performance, function, efficacy, etc. are provided as needed and they are selected based on the principal performance of the product for which approval is sought. The referenceable standards are also listed.

4. Conformity to Essential Principles

The Essential Principles conformity checklist is provided for confirming the conformity to "The medical device criteria specified by the Minister pursuant to Article 41, Paragraph 3 of the Law" (i.e., the Essential Principles). (The Essential Principle is designated by MHLW Ministerial Notification No. 122 [as of March 29, 2005].)

【Scope of medical devices to which review guidelines apply】

The "review guidelines" apply to medical devices which are substantially equivalent to precedent products in the Japanese market and improved medical devices. Clinical trial data may be necessary for some improved medical devices. New medical devices are outside of this scope.

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