When exporting medical device to Japan,
Foreign factories who manufacture the medical devices must be registered with the
Ministry of Health, Labor and Welfare of Japan.(MHLW)
When you want to accept OEM production from a Japanese company,
When you want to export your medical devce to Japan,
it is greatly advantageous for you to have your registration certificate.
This is because
this Registration certificate of foreign medical device manufacturer takes about
2 months to 5 months from the application until the certificate is issued.
If you live abroad, this application work is difficult.
Because you need to use the PC system called FD application for these tasks.
The FD application system is a Japanese system that runs on windows PC.
To apply We need the following items.
CEO or President name
Name of the factory,
Address and map image,
Responsible person’s name and his/her personal history in factory
This license has a validity period of 5 years and needs to be renewed.
New registration: license tax JPY 90,000 + our work cost
If you have any questions, please contact us from the inquiries.