FAQ

-, We are a medical agency service company to support the foreign manufacturer in Asia, Europe which does not have the license to import and sell medical devices in Japan. You foreign manufacturer can keep PMDA/Notified body license on your hand through Designated Marketing Approval Holder (DMAH) who works for maintaining your licenses as maid service. LISA posses “DMAH” license, and have experience from 2007.

-, You foreign manufacturer save a lot of cost in using “DMAH” like LISA than establishing your oun MAH setup office including hireling QA/RA/GVP managers in Japan. Our basic fee is “fixed license retainer fee” is applicable to QMS and GVP operations.

-, You foreign manufacturer can select and appint your distributor in Japan as your wish, “DMAH” distribute your product to the distributor who you apponit.

-, Yes! LISA will be supporting you along with consulting and document & dosseir preparation for submission, corresponding with authority, obtaning approval, importing your product and shipping when it is needed. Please do not hesitate to confide your concerns.

-, Yes! LISA can transfer product license/SHONIN/NINSHO class II, class III. In the case of class I product, you will need to make a new nitification. For this goal, we will provide you a copy of our notification documents on class I.

-, If you ask your distributor to become MAH in Japan to obtain and maintain license of your product, license belongs to your distributor, but does not belongs to you foreign manufacturer, which is big difference as compared to our “DMAH” service.License belongs to you foreign manufacturer under DMAH service.

-, We will not chrage any fee before signing an agreement. Thereofore, plesae feel free to contcat us.

Lisa can support to create approval application/submission document to PMDA/Notified body including correspondance service to PMDA/Notifield body for obtaining approval for you. Experinece licenses we Worled On includes such a service.