How to Confirm the JMDN (Japan Medical Device Nomenclature) of a Medical Device
1. Introduction
First, it is important to confirm whether the developed product falls under the category of a medical device, and then to identify its JMDN (Japan Medical Device Nomenclature). Once the JMDN is identified, the medical device's classification and the regulatory application procedures (Approval, Certification, or Notification) will become clear.
2. How to Confirm if a Product is a Medical Device
If you determine that the product is a medical device, the next step is to identify the specific JMDN it falls under.
If a product you believed was not a medical device is determined to be one, or if a product you thought matched an existing JMDN is judged is not an appropriate one, being either improved medical device or new medical device, there is a risk of significant setbacks in the development process, such as needing to re-collect clinical data. Therefore, it is strongly recommended to confirm with regulatory authorities like the prefectural pharmaceutical affairs division at the earliest possible stage.
For accuracy, the links provided usually lead to the original Japanese sources.
@K.Kamitani
First, it is important to confirm whether the developed product falls under the category of a medical device, and then to identify its JMDN (Japan Medical Device Nomenclature). Once the JMDN is identified, the medical device's classification and the regulatory application procedures (Approval, Certification, or Notification) will become clear.
2. How to Confirm if a Product is a Medical Device
- Confirmation from the Definition: First, review notifications that define medical devices and their intended use to determine if your product is likely to be classified as such.
- Check for Similar Products: If similar products are already on the market, check if they are treated as medical devices. The package insert, etc., will also contain the JMDN.
- In the case of SaMD (Software as a Medical Device): If the developed product is SaMD, confirm its status by referring to the flowcharts and specific examples provided in the dedicated guidelines.
If you determine that the product is a medical device, the next step is to identify the specific JMDN it falls under.
- Search the Database: Search for possible matches using keyword searches or the JMDN list in the database provided by the PMDA. The keyword search can be difficult to use, so it is important to download the JMDN list and check the definitions.
- Search Site: PMDA JMDA
- If you find a JMDN with a seemingly applicable definition: If you believe your product meets the definition of a specific JMDN, consult with the pharmaceutical affairs division of the prefectural government for final confirmation. In the case of SaMD, after reviewing the guidelines, confirm with the PMDA's one-stop consultation service for SaMD.
- When you consult with regulatory authorities, Japanese is absolutely necessary.
- Reference: About the One-Stop Consultation Service for SaMD
- List of Contact Points: List of Prefectural Pharmaceutical Affairs Bureaus
- If there is no JMDN with a seemingly applicable definition: If your product does not match any existing JMDN, it is highly likely to be considered a "new medical device" or an "improved medical device," requiring "Approval" by the PMDA. In this case as well, first consult with the pharmaceutical affairs division of the prefectural government. Along with confirming its status as a medical device, if an approval process is necessary, you should confirm the next steps (such as consulting with the PMDA).
- When consulting, be sure to thoroughly organize the following information in advance, using illustrations and diagrams.
- Name and Overview of the Product: What the product is and what functions it has.
- Intended Use and Target Users: Who will use it, in what situations, and for what purpose.
- Operating Principle/Algorithm: A technical explanation of how it works.
- Input/Output Information: What kind of information is input and what kind is output.
- Similar Products and Overseas Information: The presence of already approved products in Japan and abroad, and their classification information. Their patient inserts show JMDN.
- Draft Advertising/Promotional Materials: The content of planned displays and advertisements, such as website mock-ups and draft brochures.
- Reference: Regarding Consultation on the Applicability as a Medical Device (PMDA)
- Consultation with a Registered Certification Body: If the product is subject to "Certification" (some Class II and some Class III devices), you can consult with a Registered Certification Body and confirm through technical meetings.
- List of Certification Bodies: List of Registered Certification Bodies
- Consultation with PMDA: When a product is slated for the PMDA's pharmaceutical approval process, its JMDN and class are finalized during the official review. This decision is made in consultation with the Ministry of Health, Labour and Welfare (MHLW).
However, you can confirm the PMDA's current thinking on this matter during the development or pre-application phase. The first step is to apply for either a General Consultation or a preliminary meeting for an RS Consultation with the PMDA.
- Consultation Desk: PMDA General Consultation
- Utilizing Experts (Regulatory Affairs Consulting): You can also consult with a consulting firm specializing in regulatory affairs to get advice from a professional standpoint.
If a product you believed was not a medical device is determined to be one, or if a product you thought matched an existing JMDN is judged is not an appropriate one, being either improved medical device or new medical device, there is a risk of significant setbacks in the development process, such as needing to re-collect clinical data. Therefore, it is strongly recommended to confirm with regulatory authorities like the prefectural pharmaceutical affairs division at the earliest possible stage.
For accuracy, the links provided usually lead to the original Japanese sources.
@K.Kamitani