Application process for manufacturing sales permit

① Government administration machine translation

The application acceptance machine will explain the progress of the application.

We have confirmed that the medical equipment category is different, and more types are available according to demand.

②Confirmation or preparation of application requirements

Requirements for approval or approval.
Whether or not it matches the requirements, whether the results match or not, and whether or not the person who has the qualifications matches the requirements.
Specific requirements and points →Manufacturing permit requirements

<QMS systematic construction>
Manufacture and medical equipment requirements, standard QMS system, GVP ministerial quality management procedures, etc.→QSM system construction

③Production report book

Produced based on demand for medical equipment applications (medical equipment, etc. electronic application requirements).

One of the must-fill items is the vendor's representative (business code), any pending calls, and the current e-Gov phone application request.

④Prior confirmation and revision of application documents

The application reception department will check the application in advance.
If you have any questions or concerns, please modify the demand.

⑤Application

Administrative authority report.

⑥On-site training

When the staff member leaves the application, the current location of the application is as follows.
Please check the progress of the responsible person, check the QMS and GVP procedure, and confirm the progress of the construction of the current location.

⑦ Notification of permission

If you have any questions or concerns, you may be able to accept the offer.