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Medical device classification in Japan
Before you can legally sell your product in Japan, you must comply with the regulatory requirements of the Pharmaceutical and Medical Device Agency (PMDA), within the Japanese Ministry of Health, Labour, and Welfare (MHLW). Classification dictates the regulatory procedure for your device, so it is vitally important to determine the correct medical device classification and product code for your product before beginning the registration process.
How medical devices are classified in Japan
Medical devices in Japan are classified based on risk to the human body. The PMDA uses a tiered classification system for medical devices as shown below. Have an IVD? See this page.
- General – CLASS I (low risk)
- Specified Controlled – CLASS II (low/medium risk)
- Controlled – CLASS II (medium risk)
- Highly Controlled – CLASS III (medium/high risk)
- Highly Controlled – CLASS IV (high risk)
Your device's risk level determines your approval route. Pre-market Certification (PMC, or Ninsho) is for Specified Controlled – Class II devices. Pre-market Approval (PMA, or Shonin) is required for Controlled – Class II, Highly Controlled – Class III, and Highly Controlled – Class IV devices. Download a copy of our free chart explaining the regulatory process in Japan.
Japan Medical Device Nomenclature (JMDN codes)
The MHLW maintains a database of generic medical device descriptions with associated Japan Medical Device Nomenclature (JMDN) codes. This system is similar to the US FDA system of product codes or Global Medical Device Nomenclature (GMDN) system. Familiarity with the JMDN database and fluency in Japanese are essential to determine your device's code.
If your device's code does not exist, products must go through a new device pathway, and classification is determined by risk according to the classification rules in Yakusyokuhatsu No. 0720022. However, final determination of your device classification would be made by the MHLW.
Why choose Emergo to assist with Japanese medical device classification?
Our experienced team in Tokyo has completed hundreds of medical device consulting projects in Japan and collaborates with our global staff to provide personalized, local service.
- We specialize in medical device regulatory consulting and can help you determine the proper JMDN code and classification for your medical device or IVD.
- Our in-depth knowledge of Japanese medical device regulations ensures we can identify the appropriate regulatory pathway for your device.
- We can assist you in preparing application documents.
Please contact us if you need assistance with medical device classification or regulatory strategy in Japan.
Frequently asked questions
We have a novel device with no predicates. How do we classify our device in Japan?
Emergo can help determine the appropriate regulatory pathway and requirements for your device and/or represent you in consultation meetings with the PMDA.
How do we access the JMDN database to research the code for our device?
The JMDN database is accessible online via the PMDA website but is only published in Japanese. Emergo's office in Tokyo uses this system extensively and can assist you in determining the proper code for your product. Contact us for details.