Certification Criteria
【Definition of certification criteria】
“Certification criteria” mean the criteria for medical devices, for which compliance of medical devices is assessed by registered certification bodies that review applications of the devices. This criteria is specified by the Minister of Health, Labour and Welfare.
Based on the amended Pharmaceutical Affairs Act that came into effect in April 2005, the new marketing certification system was introduced, in which controlled medical devices among medical devices and in vitro diagnostics are to be certified by certification bodies registered by the Minister of Health, Labour and Welfare (registered certification bodies), instead of the Minister of Health, Labour and Welfare. Only medical devices for which “certification criteria” are specified are subject to certification by registered certification bodies. Medical devices complying with the criteria must be certified by registered certification bodies for marketing.
In accordance with the Pharmaceuticals and Medical Devices Act, which came into effect in November 2014, specially controlled medical devices for which “certification criteria” are specified must be certificated by registered certification bodies for marketing if the devices comply with the criteria.
(Excerpt from Article 23-2-23 of the Pharmaceuticals and Medical Devices Act．)
“A person who intends to market specially controlled medical devices, controlled medical devices or in vitro diagnostics designated based on the criteria specified by the Minister of Health, Labour and Welfare (hereafter, designated specially controlled medical device, etc.) or who manufactures designated specially controlled medical device, etc. exported to Japan in a foreign country (hereafter, foreign manufacturer of specified specially controlled medical devices, etc.), and who designates a marketing authorization holders based on Article 23-3-1 to market designated specially controlled medical device, etc. is to be certified for each product by certification bodies registered by the Minister of Health, Labour and Welfare based on Ministerial Ordinance.”
1. Specified specially controlled medical devices
【Structure of certification criteria for medical devices (Appendix 1)】
1. Scope
The Japan Medical Device Nomenclature(JMDN) subject to which the certification criteria are applicable are listed.
2. Intended use / indications
Intended use or indications subject to compliance with the certification criteria are limited.
3. Technical standards
Primary endpoints for evaluation of the equivalence to existing products are specified
【Matters necessary for compliance with certification criteria】
PFSB Notification No. 1105-2 of the Pharmaceutical and Food Safety Bureau, MHLW, dated November 5, 2014 provides matters necessary for compliance with certification criteria.
【Conformity to the Essential Principles】
It has been clarified that 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) means the conditions to meet certification criteria. A checklist of conformity to the essential principles is allowed to be used as a reference for determining conformity to the essential principles.
【Products subject to compliance with certification criteria】
Products subject to compliance with certification criteria are limited to those which are substantially equivalent in terms of structure, usage, indications and performance to existing specially controlled medical devices (so called “generic medical devices”).
【Data relating to compliance with certification criteria】
PFSB/MDRMPED Notification No. 1120-8 dated on November 20, 2014 provides a guideline for integrity of data relating to compliance with certification criteria.
2. Specified controlled medical devices
【Structure of certification criteria for medical devices (Appendix 2)】
1. Scope
The Japan Medical Device Nomenclature(JMDN) subject to which the certification criteria are applicable are listed.
2. Intended use / indications
Intended use or indications subject to compliance with the certification criteria are limited.
3. Technical standards
Primary endpoints for evaluation of the equivalence to existing products are specified
【Matters necessary for compliance with certification criteria】
PFSB Notification No. 1105-2 of the Pharmaceutical and Food Safety Bureau, MHLW, dated November 5, 2014 provides matters necessary for compliance with certification criteria.
【Conformity to the Essential Principles】
It has been clarified that 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) means the conditions to meet certification criteria. A checklist of conformity to the essential principles is allowed to be used as a reference for determining conformity to the essential principles.
【Products subject to compliance with certification criteria】
Products subject to compliance with certification criteria are limited to those which have substantially equivalent in terms of structure, usage, indications and performance to existing controlled medical devices (i.e. “generic medical devices”).
3. Specified controlled medical devices
【Structure of certification criteria for medical devices (Appendix 3)】
1. Scope
The Japan Medical Device Nomenclature(JMDN) to which the certification criteria are applicable are listed.
2. Intended use / indications
Intended use or indications subject to compliance with the criteria are limited.
3. Technical standards
Japanese Industrial Standard (JIS) is cited in principle.
【Conformity to the Essential Principles】
It has been clarified that 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) means the conditions to meet certification criteria. A checklist of conformity to the essential principles is allowed to be used as a reference for determining conformity to the essential principles.
【Products subject to compliance with certification criteria】
Products subject to compliance with certification criteria are limited to those which have substantially equivalent in terms of structure, usage, indications and performance to existing controlled medical devices (i.e. “generic medical devices”).