Importing medical devices into Japan only requires three steps of regulation. Japan PMDA approval is a requirement.
1. Medical Device Sales & Marketing License – only a Japanese company can obtain this license.
2. Foreign Medical Device Manufacturer registration – this step is required before any product can be imported.
3. Product Approval – this step allows the product to be imported into Japan.
If you are a foreign company without Japanese subsidiary, you are required to have an importer of record (IOR). The IOR can complete steps 2 and 3 on behalf of the foreign manufacturer.
Be sure to choose an IOR that does not place restrictions on your Japan sales channels. COVUE is perfect to pick as your IOR. We do not restrict sales channels. Distributors may also act as your IOR however, problems can occur if the distributor does not act as intended.