Generic Name
This is the regulatory name used to classify medical devices based on common features such as intended use and structure. A JMDN code corresponds to a generic name.
How to Find a JMDN Code
When searching for a JMDN code, do not decide based only on the name shown in the search results. Confirm the definition of the generic name, device classification, certification standards, and similar products. Before searching for candidates, organize the device's intended use, structure and principle of operation, and method of use.
JMDN Code, Generic Name, and Trade Name
Trade Name
This is the name assigned to an individual product. Multiple trade names may exist under the same generic name.
Approval, Certification, and Notification Numbers
These are numbers assigned to individual products or regulatory procedures. Their role differs from a JMDN code, which identifies a generic name.
A JMDN code is not an approval number for an individual product. It is important information for considering the regulatory positioning of a device, but the code alone does not always determine whether the applicable route is marketing approval, certification, or marketing notification.
Product Information to Prepare Before Searching
ItemDetails
Intended use
Who will use the device, at what site, and for what purpose
Structure and principle of operation
Components of the device and how it achieves its intended purpose
Contact site and duration
Site and duration of contact and whether the device is implanted
Method of use
Whether it is used alone or with another device, and whether it is single-use or reusable
Similar products
Products with similar intended use or structure in Japan or overseas and their differences
Overseas classification
GMDN, FDA product code, overseas class, approval and marketing status
Steps for Finding Candidate Generic Names
- 01
Search Using Short Keywords
Rather than entering only the product name, divide the search into short terms describing the intended use, anatomical site, function, and shape.
- 02
Read the Definition of the Generic Name
Even if names look similar, the intended use, structure, or target site described in the definition may not match the product. Review the definition for each candidate.
- 03
Confirm the Device Classification
Once a candidate generic device name has been identified, confirm the classification assigned to that generic name. For the relationship between Classes I–IV and regulatory pathways, see “Medical Device Classification in Japan.”
- 04
Check Whether Certification Standards Exist and Their Scope
If 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.”
- 05
Compare Public Information on Similar Products
Review the trade name, generic name, intended use, shape and structure, and approval or certification number to understand the differences from the product to be submitted.
PMDA Generic Name Search
This is an official database where you can check generic names, JMDN codes, definitions, and device classifications.
JMDN Search Tool
You can search for potentially applicable generic names using a product name or intended use.
Points to Watch When Reviewing Search Results
- Searching only by the product's trade name or internal name without using terms that describe its intended use or function
- Selecting a candidate only because the name looks similar, without reading the definition
- Applying the JMDN code of a similar product directly to the product to be submitted
- Looking only at the device classification without confirming the scope of the certification standards
- Assuming that a GMDN code or FDA product code corresponds one-to-one with a JMDN code
- Using inconsistent intended-use wording across the application form, labeling, package insert, and website
We Support Confirmation of JMDN Codes and Regulatory Pathways
We review the device's intended use, structure and principle of operation, contact site, and similar products to organize candidate generic names and JMDN codes, applicable certification standards, and the expected regulatory pathway.
For an overview of Japan's Class I-IV system and regulatory routes, see Medical Device Classification in Japan.
Frequently Asked Questions About JMDN Codes
If the JMDN code is known, is the regulatory pathway also determined?+
Not necessarily. In addition to device classification, confirm whether certification standards exist and their scope, the novelty of the product, and differences from existing products before determining the regulatory pathway.
Can a JMDN code be determined from a GMDN code or FDA product code?+
They can be useful for identifying candidates, but there is not always a one-to-one correspondence. The definition of the Japanese generic name must be compared with the intended use and structure of the product to be submitted.
Can we use the JMDN code shown in the package insert of a similar product?+
A similar product and the product to be submitted may differ in intended use, structure, performance, or risk. Use it as reference information and determine the appropriate code from the definition of the generic name and the characteristics of the product to be submitted.
What should we do if the search tool returns multiple candidates?+
Compare the definition, class, certification standards, and similar products for each candidate and identify the one that is closest to the product to be submitted. If the judgment is difficult, PMDA consultation is also an option.
We Review Candidate JMDN Codes and Regulatory Pathways from Product Information
Share the intended use and main specifications. You can contact us before the JMDN code is determined.
Contact us about JMDN codes