In principle, it is necessary to take the same procedures as the drug registration,
but the required time and procedure are comparatively short and simple.
Foreign pre-clinical and clinical data, in principle is accepted with some
exceptions. It is, however, faster and less expensive to produce some pre-clinical
data in Japan.
MBS has a wide range of product registration experience; ranging from disposable products to medical electronic products.
In order to extend the life cycle of your product upon completion of product
registration in abroad you should start preparation of the product registration
Japanese MHLW. MBS will assist in the procedures marked with your company.
Now, we have changed Pharmaceutical Law in April, 2005