How to Check Medical Device Certification Standards in Japan
Even when certification standards have been established for a generic name, not every product is eligible for a certification application. Check whether standards exist for the JMDN code and then confirm whether the intended use, structure and principle of operation, and performance of the product fall within the scope.
Check the Scope, Not Only Whether Certification Standards Exist
Third-party certification is available for designated highly controlled medical devices and other designated devices for which certification standards have been established and whose products fall within the applicable scope. Even when the generic name and device classification match, a product may not be eligible for certification if its intended use, structure and principle of operation, performance, or other characteristics fall outside the scope of the standards.
Related guide: Certification vs Approval for Medical Devices in Japan
Information to Prepare Before Checking Certification Standards
Target disease, anatomical site, method of use, and intended user
Main components, operating principle, energy source, and whether the device is implanted
Performance items, risks, applicable standards, and test results for the product to be submitted
Candidate JMDN code, definition, and device classification
Similarities and differences between the product to be submitted and certified or approved products in Japan
Planned intended-use wording, warnings, contraindications, operating instructions, and advertising claims
Steps for Checking Certification Standards and Certified Products
- 01
Confirm Candidate Generic Names
Based on the intended use, structure and principle of operation, and contact site, confirm candidate generic names and JMDN codes.
- 02
Check Whether Certification Standards Exist
Use PMDA's standards information to confirm whether certification standards have been established for the generic name.
- 03
Read the Scope
Review the intended use, structure, performance, exclusions, and other requirements to determine whether the product to be submitted falls within the scope of the certification standards.
- 04
Check Referenced Standards and Test Methods
Review the Japanese Industrial Standards and evaluation items referenced by the certification standards and determine whether the existing documentation can address them.
- 05
Search the Certified Medical Device List for Similar Products
For certified products with the same generic name, review the trade name, certificate holder, certification number, and related information to understand differences from the product to be submitted.
- 06
Consult a Registered Certification Body
If judgment is required regarding the applicability of the standards, prepare the product information and questions and consult a Registered Certification Body (RCB).
PMDA Generic Name Search
You can check generic names, JMDN codes, device classifications, and links to certification standards.
PMDA Certified Medical Device List
You can review public information on medical devices certified by Registered Certification Bodies.
Five Items to Check Within the Scope of Certification Standards
Whether the intended purpose or indications exceed the scope specified in the standards
Whether the structure, operating principle, materials, and energy source are consistent with those contemplated by the standards
Whether the required performance items, standards, and test methods can be met
Whether additional functions or new methods of use affect effectiveness or safety
Whether the intended use, warnings, contraindications, and operating instructions are consistent with the certified scope
Points to Watch When Considering the Certification Route
- Assuming that certification is available based only on the JMDN code and device classification
- Confirming only that certification standards exist without reading the standards and their scope
- Failing to compare the intended use, performance, and structure of similar certified products with the product to be submitted
- Failing to confirm whether the version of a referenced standard or the test conditions match the documentation for the product to be submitted
- Consulting a Registered Certification Body without first organizing the product specifications and questions
- Using labeling or website claims that indicate intended uses or performance beyond the certified scope
Frequently Asked Questions About Certification Standards
If certification standards exist, does that always mean the application will be a certification application?+
No. Even when certification standards exist, the product to be submitted may not fall within their scope. Confirm the intended use, structure and principle of operation, performance, and differences from existing products.
Are all Class II medical devices certified?+
No. If no certification standards exist for the applicable generic name, or if the product falls outside their scope, a marketing approval application may need to be considered.
Can a Class III device be certified?+
If it falls within a category designated for third-party certification and is within the scope of the applicable certification standards, certification by a Registered Certification Body may be available.
If a product does not meet the certification standards, can it not be marketed in Japan?+
Even if a product is outside the certification standards, it may still be possible to market it in Japan through another regulatory procedure, such as a marketing approval application. The required documentation and review timeline differ from those for certification.
We Review the Scope of Certification Standards and the Regulatory Pathway
We review the product specifications, candidate JMDN codes, and similar products and consider the appropriate strategy, including consultation with a Registered Certification Body or a marketing approval application.
Related guide: How to Search the Certified Medical Device List in Japan · For application support: Approval, Certification & Notification Support
Contact us about certification standards