Importing medical devices into Japan requires Japan PMDA (FDA) approval. There are three steps of regulation:
If you are a foreign company without Japanese subsidiary, you will require an Importer of Record (IOR). Only the IOR can complete steps 2 and 3 on behalf of the foreign manufacturer.
It’s imported to note that your IOR will control your product marketing rights. Ensure that you choose an IOR that does not place restrictions on your Japan sales channels. COVUE does not restrict sales channels. Distributors can act as your IOR. However, choosing distributor as your IOR can lead to problems if that distributor does not perform as expected.
Process for Completing steps 2 and 3.
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