Application flow for manufacturing and sales business license
Updated: July 2025, 10
When obtaining a medical device permit, the application process is as follows.
①Consult with administrative agencies
You will receive an explanation from the institution to which you will apply.
Check the classification of the medical device being handled and what type of permit is required.
② Confirmation of application requirements and preparation of requirements
Check the requirements for the license you are obtaining.
Check whether your company meets the requirements, and if there are any deficiencies, meet the requirements by hiring qualified personnel.
Click here for requirements →Manufacturing and sales license requirements
<Construction of QMS system>
Manufacturing and sales businesses are required to have procedure manuals based on the QMS system ministerial ordinance and GVP ministerial ordinance.→About QMS system
③ Creation of application form
Application forms for medical devices are created by entering the necessary information into special software (electronic drug application software).
One of the required items is a vendor code, and if you do not have one, apply for one from the e-Gov electronic application application.
④Pre-confirmation and correction of application forms
The application form will be checked in advance at the administrative agency to which you are applying.
If there are any deficiencies, we will make corrections.
⑤Application
Apply at the administrative agency.
⑥ Field survey
A reviewer will visit the application address directly and conduct an on-site investigation based on the application documents.
We will confirm the person in charge, confirm the QMS/GVP procedure manuals, and confirm the location and structure.
⑦Permission notification
If there are no problems as a result of the examination, you will receive a permit.
Our company provides total support from ① to ⑦ of medical device permit application.
The first consultation is free.
