【Definition of approval criteria】

“‘Approval criteria’ mean the criteria, compliance with which is assessed for regulatory approval of medical devices.” ‘Approval criteria’, composed of ISO or IEC standards, etc., in principle, are intended for products for which no clinical data are required to be submitted.” (See PFSB Notification No. 1120-5, dated on November 20, 2014)

Approval criteria identify uniform technical requirements and are described for objective assessment of compliance with the criteria.

(Excerpt from Article 23-2-5 of the Pharmaceuticals and Medical Devices Act)

“A person who intends to market medical devices (excluding general medical devices, and specially controlled medical devices and controlled medical devices designated in Article 23-2-23 Paragraph 1) or in vitro diagnostics (excluding products which are designated based on criteria specified by the Minister of Health, Labour and Welfare and which are s designated in the same paragraph) must receive approval for marketing of each product.”

【Structure of approval criteria for medical devices】

1. Scope

The Japan Medical Device Nomenclature(JMDN) to which the approval criteria are applicable are listed.

2. Technical standards

Items related to performance, function, efficacy etc. are specified.

3. Intended use / indications

Intended use or indications subject to compliance with the criteria are limited.

【Conformity to the Essential Principles】

A checklist of conformity to the essential principles specified in “the Criteria for medical devices as stipulated by the Minister of Health, Labour and Welfare in accordance with Article 41, Paragraph 3 of the Pharmaceuticals and Medical Devices Act” (Ministerial Announcement No. 122, dated on March 29, 2005) is prepared for each provision.

【Products subject to compliance with approval criteria】

Products subject to compliance with approval criteria are limited to those which are substantially equivalent in terms of structure, usage, indications and performance to existing approved products (i.e. “generic medical devices”) and for which no clinical data are required to be submitted.

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