Generic device name
Identify the applicable Japanese generic device name based on the intended use, structure, principle of operation, and other relevant device characteristics.
CLASSIFICATION / JMDN
Medical Device Classification in Japan
Medical devices in Japan are classified from Class I to IV according to their risk to the human body. However, classification alone does not determine whether marketing notification, certification, or approval is required.
Review the generic device name, JMDN code, certification standards, intended use, and product characteristics together.
OVERVIEW
A product name alone does not determine classification or the regulatory procedure
Devices that appear similar may fall under different generic device names because of differences in intended use, site of use, contact duration, materials, design, operating principles, or sterilization status.
A different generic device name may also mean a different classification, certification standard, or regulatory procedure.
FDA and EU MDR classifications may provide useful reference information, but they do not directly determine classification in Japan.
RISK CLASS
Classes I–IV and the typical regulatory procedures
ClassRegulatory categoryTypical regulatory procedure
Class I
General medical devices
Marketing notification in principle
Class II
Controlled medical devices
Certification when covered by certification standards; marketing approval when certification is not applicable and approval is required
Class III
Specially controlled medical devices
Marketing approval; certification for certain designated devices
Class IV
Specially controlled medical devices
Marketing approval
This table shows the general relationship. The actual procedure must be determined by reviewing the generic device name, certification standards, product characteristics, and other relevant factors.
GENERIC NAME / JMDN
How generic device names, JMDN codes, and certification standards relate
JMDN code
The JMDN code corresponds to the Japanese generic device name. For the search process, see “How to Find a JMDN Code.”
Classification
Each generic device name has an assigned classification. Classification alone does not determine the regulatory pathway, so the availability and scope of certification standards must also be checked.
Certification standards
When a certification standard exists, confirm whether the device falls within its scope. For the detailed process, see “How to Check Medical Device Certification Standards in Japan.”
Find candidate generic device names and JMDN codes
Search for candidate generic device names and JMDN codes using product names or intended applications.
REGULATORY ROUTE
Check the regulatory procedure using classification and certification standards
Marketing notification
Primarily applies to Class I general medical devices.
Certification
Applies to Class II and certain Class III medical devices covered by certification standards.
Approval
Applies to devices that are not eligible for certification and require marketing approval.
Use the classification findings to plan the registration pathway for medical devices in Japan
Related guide: Certification vs Approval for Medical Devices in Japan
PROCESS
How to determine the classification and required regulatory procedure
- 1
Organize the product information
Review intended use, target patients, contact site and duration, design, operating principles, materials, and sterilization status.
- 2
Identify candidate generic device names
Compare the product's characteristics with the definitions of generic device names to narrow down the candidates.
- 3
Check the classification
Confirm the class and regulatory category associated with the generic device name.
- 4
Check whether certification standards apply
If certification standards exist, check whether the intended use, design, operating principles, performance, and other characteristics fall within their scope.
- 5
Compare previously approved or certified devices
Assess how differences from existing devices may affect performance, safety, or clinical evaluation.
- 6
Determine the required procedure
Consider whether marketing notification, certification, or approval is appropriate, and whether consultation with PMDA or a registered certification body is needed.
PITFALLS
Common causes of classification errors
- Applying an overseas product name or classification directly to Japan.
- Looking only at the name of a generic device category without checking its definition.
- Assuming certification is possible simply because certification standards exist.
- Failing to check the scope of the certification standards.
- Overlooking the regulatory position of accessories or devices used in combination.
- Missing differences in intended use, design, or performance compared with existing devices.
- Starting tests or preparing documents before the classification is clear.
FAQ
Questions about classification
Can we use the overseas classification in Japan?+
Overseas classifications can be useful reference information, but they do not directly determine classification in Japan. Review the Japanese generic device name, JMDN code, intended use, design, and operating principles.
Can every Class II device be submitted to a registered certification body?+
Even for Class II devices, applicable certification standards must exist and the device must fall within their scope. Some devices are not eligible for certification and require marketing approval.
Can we seek advice before identifying the JMDN code?+
Yes. Candidate generic device names and JMDN codes can be considered using the intended use, design, operating principles, similar products, and overseas approval and sales status.
Can devices of the same general type require different procedures?+
Yes. Differences in intended use, design, operating principles, materials, and performance may affect the generic device name or the applicability of certification standards.
Official Sources
For device classification, generic names and JMDN codes, refer to the following official sources.
CONTACT
Discuss classification even before the JMDN code is confirmed
We review the intended use, design, operating principles, similar products, and overseas approval and sales status to identify candidate generic device names, JMDN codes, and the relevant regulatory procedure.
Discuss medical device classification