Our Business

♦ We are here to assist you if you are planning to introduce medical devices in Japan and negotiate with the PMDA.

♦ We can also meet the needs of GPOs and others who want to reduce the cost of purchasing medical devices as much as possible.

Do you know what it takes for your company to introduce your medical products into Japan?

1. Foreign Manufacturer Registration (FMR)

　Even if you do not have a company in Japan, you can sell your products by obtaining your FMR.

　If your company outsources assembly or sterilization processes, you will need to obtain FMRs for each company.

2. Product approval

　Medical devices are classified into four categories in Japan.

　Class I　   Marketing Notification (Extremely Low Risk Medical Devices)

　Class II　  3rd party Certification (Low Risk Medical Devices)

　Class III　 Minister’s Approval on basis of PMDA review (Risk Medical Devices)

　Class IV　 Minister’s Approval on basis of PMDA review (High Risk Medical Devices)

　While it is not difficult to obtain approval for Class 1 and Class 2 medical devices,

    the cost of Class 2 medical devices is 6 to 7 times higher. 

    In Japan, the MDR (Medical Device Regulation) is required as in the US. In Europe, the MDD was in effect until May 26, 2021,

    when it will be replaced by the MDR.

3. Clinical data (Class III & IV)

　Pre-clinical Study data 

　Clinical Trial

　Post Marketing Surveillance (PMS)

    In Japan, as in the US., biological safety evaluations must be conducted according to GLP standards,

    and ISO-standard biological safety data cannot be used to apply for approval in Japan.

：To be continued later