For medical device or in-vitro diagnostic device registration, a copy of the medical device business permit is need. Those who manufacture medical devices shall attach a copy of the medical device manufacturing permit. Those who import medical devices shall attach a copy of the medical device dealer permit showing that the business category includes "medical device import."

    For domestic contract manufacturing, both the contract party and the contract manufacturer's medical device business permits shall be submitted.

    The copy of medical device business permit must be printed in A4 format. For companies without such permit, the permit can be applied for at the local health bureau.