Medical device permit work menu
Updated: July 2024, 9
At Support Administrative Scrivener Corporation, one of our specialized fields is application for permits and licenses related to medical devices and operational support for business operators.
We are not just experts in creating documents. We are experts in helping businesses starting new businesses smoothly, and businesses that have already received permission to operate businesses based on legal compliance.
There are many consultants with specialized know-how in the medical device business, but we have the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
We fully support our clients' business operations by making full use of our know-how and track record.
Please use Support Administrative Scrivener Corporation as your partner for your medical device business.
Our dedicated staff handles cases nationwide.
Support menu for new businesses and companies entering the market
We specialize in providing start-up support for medical device businesses.
We provide the following support for new businesses and companies entering the market.
・Survey on suitability of medical devices and confirmation of class classification
・Application agency for manufacturing and sales business licenses and manufacturing business licenses
・Medical device approval application, certification application, manufacturing and sales notification consulting
・QMS construction consulting
・Internal system construction consulting
Support menu for overseas medical device manufacturers expanding into Japan
We support overseas medical device manufacturers when they expand into Japan.
・Survey on suitability of medical devices and confirmation of class classification
・Matching with agencies and partners
・Application agency for foreign manufacturer registration
・Application agency for manufacturing and sales business licenses and manufacturing business licenses
・Medical device approval application, certification application, manufacturing and sales notification consulting
・QMS construction consulting
Support menu for companies in the medical device manufacturing/sales/manufacturing industry/sales/repair industry
For companies that already have a license and handle medical devices, we provide the following application agency and consulting services.
・Permit renewal and new acquisition
・New product approval/certification/notification consulting
・Applications required for importing and exporting medical devices
・QMS construction consulting
・Procedure manual creation consulting
・Insert document creation consulting
・Instruction manual, packaging, label creation consulting
・Internal audit implementation support
Application/consulting menu
Medical device manufacturing and sales business license related
| Application/consulting menu | Message |
| Application for medical device manufacturing and sales business license | We will act on your behalf to apply for Type 1, Type 2, and Type 3 medical device manufacturing and sales business licenses to prefectures. We will also witness the on-site inspection. |
| Application for renewal of medical device manufacturing and sales business license | We will act on your behalf to apply for renewal of medical device manufacturing and sales business every five years. We will also witness the on-site inspection. |
| Notification of change in medical device manufacturing and sales license | We will handle change notifications on your behalf when the following changes occur regarding medical device manufacturing and sales business licenses. ・Applicant's address and name (registered address and name in the case of a corporation) and name of office, etc. ・Change of main office location ・Officers who carry out business ・General manufacturing and sales manager ・Name and address of general manufacturing and sales manager |
Medical device manufacturing industry registration related
| Application/consulting menu | Message |
| Medical device manufacturing industry registration application | We will act on your behalf to apply for medical device manufacturing industry registration to prefectures. We will also witness the on-site inspection. |
| Medical device manufacturing industry registration renewal application | We will act on your behalf to apply for renewal of medical device manufacturing and sales business every five years. We will also witness the on-site inspection. |
| Medical device manufacturing industry registration change notification | Regarding medical device manufacturing industry registration, we will handle change notifications on your behalf when the following changes occur. ・Applicant's address and name (registered address and name in the case of a corporation) and name of office, etc. ・Officers who conduct business ・Responsible engineer ・Name and address of responsible engineer |
Medical device repair business license related
| Application/consulting menu | Message |
| Application for medical device repair business license | We will act on your behalf to apply for medical device repair business licenses to prefectures. We will also witness the on-site inspection. |
| Application for permission to add/change medical device repair category | We will act on your behalf to apply for permission to add or change categories for medical device repair business licenses. |
| Medical device repair business license renewal application | We handle renewal applications for medical device repair business licenses every five years. We will also witness the on-site inspection. |
| Medical device repair business license change notification | We will handle change notifications for medical device repair business licenses in the event of any of the following changes. ・Applicant's address and name (registered address and name in the case of a corporation) and name of office, etc. ・Structural equipment ・Officers who conduct business ・Responsible engineer ・Name and address of responsible engineer ・Abolition of repair classification |
Medical equipment sales industry related
| Application/consulting menu | Message |
| Application for sales and rental business license for highly controlled medical equipment, etc. | We will act on your behalf to apply for permission to sell or lend highly controlled medical equipment to prefectures. We will also witness the on-site inspection. |
| Managed Medical Equipment Sales/Rental Business Notification | We will act on your behalf to apply for managed medical equipment sales and rental business notifications. |
Procedures for medical device items
| Application/consulting menu | Message |
| Medical device manufacturing and sales approval application Application for approval of partial changes to medical device manufacturing and sales approval matters Application for approval to manufacture and sell foreign-manufactured medical devices Application for approval of partial changes to foreign-manufactured medical device manufacturing and sales approval matters Notification of minor changes in medical device manufacturing and sales approval matters Notification of minor changes to the manufacturing and sales approval of foreign-manufactured medical devices Application for conformity inspection of medical devices and in vitro diagnostic drugs (QMS inspection) Foreign-manufactured medical devices/in vitro diagnostic drugs Compatibility investigation application form (QMS investigation) Medical device conformity investigation application form for export (QMS investigation) Medical device manufacturing and sales approval succession notification Notification of Succession of Manufacturing and Sales Approval for Foreign Manufactured Medical Devices and In-Vitro Diagnostic Drugs Manufacture of medical devices for export/import notification Notification of Change of Appointed Manufacturer/Seller of Foreign Manufactured Medical Devices/Special Approval Holder of Foreign Manufactured Medical Devices, etc. | We provide support and consulting regarding applications for approval of Class III/IV medical devices. |
| Application for manufacturing and sales certification of designated highly controlled medical devices Application for manufacturing and sales certification of designated controlled medical devices Application for conformity investigation of designated highly controlled medical devices, etc. Application for partial change of designated highly controlled medical device manufacturing and sales certification matters Application form for partial change of designated controlled medical device manufacturing and sales certification matters Designated highly controlled medical device certification minor change notification Designated controlled medical device certification matters minor change notification | We will act on your behalf to apply to certification bodies for Class II medical devices and Class III certified medical devices. |
| Medical device manufacturing and sales notification Notification of changes in medical device manufacturing and sales notification items | We will handle the notification of Class I medical devices to PMDA on your behalf. |
QMS construction consulting
| Application/consulting menu | Message |
| Creation of new QMS procedure manual | When making a new application, we will create a QMS procedure manual tailored to your company. |
| Review of QMS procedure manual | We will carefully examine the information currently in use and make corrections and improvements to the content. Review procedure manuals from a legal compliance perspective. |
| Support for creating regular documents | We regularly check documents and records, such as once every three months, and continuously support appropriate QMS operations. |
| internal audit support | We not only create internal audit check sheets and provide actual internal audit support, but also provide post-internal audit results reports and management reviews. |
| Educational training support | We support sustainable education and training by proposing annual education and training plans and supporting the creation of records. |
