Medical device vendor change procedures
Updated: July 2025, 10
There are various changes that occur in corporate activities, such as changing the company name, relocating, transferring or relocating executives and managers, and discontinuing the business.
However, even if the change is a common one like the one mentioned above, if the company is a manufacturer, distributor, or manufacturer of medical devices, prompt procedures may be a must.
in this case,The scary thing is missing the deadline without realizing it.AndIt is discovered that the change no longer satisfies the requirements for permission or registration.
This is a major incident that affects the life of the company.
In order to avoid such a situation, it is necessary to accurately understand "changes that require modification procedures" and "changes that are unnecessary" and take appropriate measures.
We at Support Administrative Scrivener Corporation have extensive experience in handling procedures associated with changes in manufacturers and manufacturers of medical devices.
If you are considering any changes, please contact us.
We will explain the procedures that will be required due to the change, and then propose the optimal response for your company's case.We will thoroughly handle everything from collecting materials to actually handling the procedures, including negotiations with the applicant. We will support you.
Below, we will provide a general overview of the procedures associated with the changes.
Medical device vendor change procedure flow and points to note
If a change procedure is required, the details of the notification and points to note will vary greatly depending on the details of the change.
In addition, in some cases, it may be necessary to undergo another on-site inspection, resulting in a blank period for the project. Caution is required.
What changes should be carried out?
It is abbreviated as follows.
Law = Act on ensuring the quality, effectiveness, and safety of pharmaceuticals, medical devices, etc.
Enforcement Regulations = Enforcement Regulations of the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc.
Changes for which a change notification must be submitted are stipulated in the Enforcement Regulations, and are summarized in the table below along with common examples.
(Enforcement Regulations Article 114-69 and 70)
This also applies to changes in foreign manufacturers.
| Change | Common examples | Manufacturing and sales business | Manufacturing industry |
| Name | For corporations, change of trade name, change of corporate personality, etc. For individuals, name change including marriage, divorce, and succession of name | want | want |
| Address | Relocation, floor change, building name change, residence display change, etc. | want | Required *1 |
| Name and location of the office with the main function*2 | Trade name change, relocation, floor change, building name change, residence display change, etc. | want | Not applicable |
| Factory name | Trade name change | Not applicable | want |
| In the case of a corporation, the name of the officer conducting the business | Retirement, new appointment, change of officer, marriage, divorce, name change including succession, death, etc. | want | want |
| Name and address of person in charge (general manufacturing and sales manager/responsible engineer) | Retirement, personnel changes, marriage, divorce, name change including succession, moving, etc. | want | want |
| When receiving another type of marketing license or discontinuing the business related to the license | Business restructuring, etc. (cosmetics, quasi-drugs, pharmaceuticals, etc.) | want | want |
Change notifications will be made by submitting Form No. 6 (Article 114-69 and 70 of the Enforcement Regulations).
*1: A change in the manufacturer's address refers to a change in the address of the manufacturer. If the manufacturer moves, a new registration application and abolition notification are required.
*2: When relocating an office with the main functions of a manufacturing/distributing agent to another prefecture, it is necessary to apply for a new license in the destination prefecture and to submit an abolition notification in the previous prefecture, rather than changing the office. becomes.
Deadline for change procedure
If there is a change in the licensing or registration matters, the marketing authorization holder and manufacturer of medical devices must submit a change notification to the prefectural governor along with the necessary documents within 30 days from the date of the change. not.
(Article 23-2-16, paragraphs 1 and 2 of the Act)
At this time, if necessary, you will also apply for a renewal of your license or registration certificate.
However, if new application procedures are required, permission or registration procedures are required in advance.
This is because retrospective permission or registration is not possible.
Since on-site inspections may also be required, we recommend that you consider this carefully with several months in advance from the planning stage.
Please contact the support administrative scrivener corporation.
As mentioned above, we at Support Administrative Scrivener Corporation have extensive experience in handling procedures related to changes in manufacturers and manufacturers of medical devices.
Our specialized staff handles various applications for our customers quickly and reliably.
We also have offices in four locations across the country, in Tokyo, Nagoya, and Osaka, and can provide nationwide service from these bases.
We also accept inquiries from overseas via the Internet.
We also have staff who can speak Chinese, English, and Korean, so we can help you even if it is difficult to consult in Japanese.
Please leave the specialized and complicated procedures to us.
The first consultation is free.
Our dedicated staff handles cases nationwide.
