Is this product a medical device? Where to ask and how to check
Medical device status refers to whether a product is a medical device under Japan’s PMD Act. If you are unsure, review the product’s intended use and functions before considering its classification or submission pathway.
1. Where can you seek advice?
You can consult the pharmaceutical affairs department of a prefectural government about whether a product is a medical device. For software, PMDA accepts inquiries through its SaMD consultation service.
Businesses can contact these authorities directly. Organizing the information you need to explain can help the consultation move forward.
2. Information to prepare before a consultation
Prepare materials that explain what the product is for, who it is intended for, and how it is used.
- Intended use, intended users or target population, and method of use
- Specifications, including functions, design and operating principles, physical form, and materials
- Proposed indications and effects, and the content of instructions and advertising
- Information on similar products and overseas approval and sales status
You do not need to fill in details that have not yet been decided during development. Separate what has been decided from what still needs to be confirmed.
3. How MK Consulting can help
We review product documentation to identify information missing for the consultation and inconsistencies between the intended use, specifications, and descriptive wording. We then organize the questions to raise with the authorities and help prepare consultation materials.
If you are unsure whether your product is a medical device, consult the relevant authority. We can help organize the information needed for that consultation in a clear, understandable form.
4. What comes next if the product is a medical device?
Check the Japanese generic device name, JMDN code, and classification, then consider which procedure is required: approval, certification, or notification.
For guidance on the next steps, see:
5. Frequently asked questions
How does medical device status differ from classification?
Medical device status asks whether a product is a medical device. Classification asks which device class it falls into.
Can we seek advice before the product specifications are finalized?
You can consult us while your product is still in development. Based on the current intended use and specifications, we identify what needs to be decided and confirmed in preparation for a consultation.