Frequently Asked Questions
We have multiple manufacturing facilities. Do we need to register all of them?
Under the PMD Act, you are required to obtain registrations for the manufacturing sites that fall within the registration scope. Foreign-based manufacturers must register facilities responsible for product design and development, primary manufacturing, or sterilization. Relevant contract manufacturers must also be registered. Emergo can you assist you with identifying which sites require registration.
What is the self-declaration of medical condition (Someisho)?
A self-declaration of medical condition is required documentation for FMR application. The responsible person must submit a self-declaration that they are mentally competent and have no drug addictions.
Are the business number and its serial code needed before we submit our device registration?
The Foreign Manufacturer Registration is also required before you may submit your FMR, which precedes your device registration submission to the MHLW.
We lost our Foreign Manufacturer Registration Certificate. Do we need to re-submit the registration?
In the event of a lost FMR certificate, you must submit a letter to the MHLW explaining why and how it was lost or destroyed. The MHLW may re-issue an original certificate based on the content of your letter. Emergo can assist with certificate reissue requests to the MHLW. Please keep the original of the certificate in a safe place because you must return it to MHLW when submitting FMR renewal application.
Does our Foreign Manufacturer Registration need to be renewed?
Yes, your FMR must be renewed every 5 years. The MHLW recommends beginning the renewal process at least five months in advance of your certificate’s expiration date.