Succession of approval/certification
Updated: July 2025, 10
Support Administrative Scrivener Corporation provides support for notification of succession of products that have received medical device manufacturing and sales approval and medical device manufacturing and sales certification.
We will support those who are completing the procedure for the first time, or those who find it difficult to handle it in-house, with our resources and know-how.
Do you have any trouble with medical device manufacturing and sales approval or notification of succession of medical device manufacturing and sales certification?
“I want to take over product inheritance/certification, but do I have to spend a huge amount of money and effort to go through the process from scratch?”
"I want to take over a product from a company that is having difficulty continuing its business, but I don't have much time left."
Please contact us by all means.
Cases in which succession of medical device manufacturing and sales approval/certification is permitted
| ① | In case of inheritance/merger In case of inheritance, merger, or division of a manufacturing/sales company that has obtained approval/certification. The successor is required to inherit all materials and information regarding the quality, effectiveness, and safety of the medical device related to the succession/certification. |
| ② | In case of contract When a marketing authorization holder that has obtained approval and certification transfers all materials and information regarding the quality, efficacy, and safety of the inherited pharmaceuticals, etc., for the purpose of passing on the status through a contract with a successor. |
Timing to apply for succession of medical device manufacturing and sales approval/certification
| In case of inheritance | In case of inheritance, without delay after succession |
| In case of merger, contract, or split | 5 months before the scheduled date of succession |
Conditions for succession of medical device manufacturing and sales approval/certification
| ① | The approved matters will be inherited without any changes. |
| ② | In principle, those that have been approved for less than one year, and those that are undergoing a complete change application, cannot be inherited. |
Procedure flow
First of all, please tell us about your situation.
If the receiving company does not have a license to manufacture and sell medical devices, the procedure begins with obtaining the license.
We will guide you through the necessary documents and create the documents.
We can handle everything from document creation to submission on your behalf.
Related support menu
We handle services related to medical devices, focusing on the following services.
Medical device manufacturing and sales license ｜ Supporting applications to each prefecture
Medical device manufacturing industry registration ｜ Supporting applications to each prefecture
Manufacturing and sales notification of medical devices ｜ Supporting applications to the Pharmaceuticals and Medical Devices Agency
Medical device certification application ｜ Support for applications to third-party certification bodies
Medical device approval application ｜ Supporting applications to the Pharmaceuticals and Medical Devices Agency
QMS/GVP procedure manual creation ｜ Supporting the creation of procedure manuals required by marketing distributors and manufacturers
QMS measures for renewal surveys ｜ Supporting operation of procedure manuals
Medical device applicability classification survey ｜ Contracted to investigate the applicability and classification of medical devices
Medical device approval acquisition plan ｜ Create plans and budgets to obtain approvals and certifications
Evaluation test implementation support ｜ Support for implementation of evaluation tests at external testing institutions
In particular, when there is a succession, there will be problems with the system and operation of the system.QMS/GVP procedure manual creationWe frequently receive requests for this service.
Please contact us.
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
We provide legal services related to medical devices based on 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.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
