How to Search the Certified Medical Device List in Japan
The certified medical device list allows you to check the trade name, generic name, certification number, certification date, certificate holder, and Registered Certification Body code. JMDN codes are not a listed field in the certified medical device list; check them separately using PMDA's generic-name search. When searching for similar certified products, do not rely on the list alone; also review the applicable certification standards and publicly available documents.
Differences Between Certification Numbers, Approval Numbers, Notification Numbers, and JMDN Codes
A number assigned to an individual product certified by a Registered Certification Body. It is used to identify the certified product and check public information.
A number assigned to an individual product approved by the Minister of Health, Labour and Welfare. The regulatory procedure and review body differ from those for certification.
A number related to a product for which a marketing notification has been submitted. It is mainly used for Class I general medical devices.
A code corresponding to a generic name. It is used to confirm the regulatory positioning of a product group rather than identify an individual product.
Information Available in the Certified Medical Device List
Official trade name of the certified product
Generic name for the product
Number identifying the individual product and date of certification
The entity that holds certification for the product. If the holder is overseas, also check the separately listed designated Japanese MAH.
Code identifying the organization that conducted the certification review
Information such as withdrawal or cancellation when published
PMDA Certified Medical Device List
You can review annual lists from PMDA's page for published certified products.
Certified Medical Device Search Tool
You can search for candidate products using the trade name, generic name, certification number, certificate holder, and other fields in the certified medical device list. Check JMDN codes separately using PMDA's generic-name search.
Steps for Finding Similar Certified Products
- 01
Confirm the Product Characteristics
Review the intended use, structure and principle of operation, performance, contact site, and names of similar products.
- 02
Find Candidate Generic Names
Use a JMDN search to identify candidate generic names and confirm their definitions and device classifications.
- 03
Search the Certified Medical Device List
Use the generic name, trade name, certificate holder, and other terms to find certified products with similar intended use or structure.
- 04
Review Public Documents
Review the intended use, shape and structure, method of use, warnings, and contraindications in package inserts and other public documents.
- 05
Check the Scope of the Certification Standards
Even if a similar product has been certified, separately confirm whether the product to be submitted falls within the scope of the same certification standards.
- 06
Identify Differences from the Product to Be Submitted
Assess whether differences in additional functions, materials, performance, intended use, operating method, or other characteristics may affect eligibility for certification or the documentation required.
If You Cannot Find the Product
No search result does not necessarily mean the product is not marketed in Japan. It may be an approved product or a notified product, the brand name may differ from the regulatory trade name, or the certificate holder may have changed. Try different search conditions such as part of the trade name, generic name, or Marketing Authorization Holder, and review package inserts and company public information as needed.
Commonly Overlooked Points When Researching Certified Products
- Searching only for an exact trade-name match without using the generic name or intended use
- Assuming that the product to be submitted can also be certified simply because a certified product with the same generic name exists
- Assuming from the certified medical device list alone that the intended use or structure is the same
- Failing to confirm the version, scope, and referenced standards of the applicable certification standards
- Failing to consider differences between the certificate holder and the actual distributor or brand name
Frequently Asked Questions About the Certified Medical Device List
If there is a certified product with the same generic name, can our product also be certified?+
Even with the same generic name, the intended use, structure and principle of operation, or performance may fall outside the scope of the certification standards. The existence of a similar product alone is not sufficient to determine eligibility for certification.
Why can't I find a product in the certified medical device list?+
It may be an approved or notified product, the trade name may be written differently, the certificate holder may have changed, the certification may have been withdrawn or cancelled, or the public information may not yet have been updated.
Can the certified medical device list show detailed product specifications?+
The list alone may not provide detailed specifications. Also review package inserts and company public information, and conduct additional research when necessary.
Are all Class II medical devices certified products?+
No. Products for which no certification standards exist, or products outside the scope of the applicable standards, may require a marketing approval application.
We Compare Similar Certified Products with the Product to Be Submitted
We review the generic name, existing certified products, package inserts, and certification standards to advise on the regulatory pathway and documentation that should be considered for the product to be submitted.
Related guide: How to Check Medical Device Certification Standards in Japan · For application support: Approval, Certification & Notification Support
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