In vitro diagnostic drug license approval - Support Administrative Scrivener Corporation

Medical equipment/cosmetics/pharmacies

In vitro diagnostic drug license approval

Updated: July 2025, 10

You can ask us about "What are in vitro diagnostic reagents?"

　
The field of in vitro diagnostic drugs is extremely complex, and it would be extremely difficult for a general company to start from scratch.

At our company, our professional staff with knowledge and experience will provide support to our customers.

We have offices in four locations across the country, including Tokyo, Nagoya, and Osaka, and can provide services nationwide.

Leave the professional and complicated procedures to us!

Free Consultation (Contact Us)

▼▽▼Contents that we often consult with our company▼▽▼

☑ I want to obtain a manufacturing and sales license for in vitro diagnostic drugs. 　
☑ I want to enter the field of in vitro diagnostic drugs 　
☑I want to import in vitro diagnostic drugs from overseas. 　
☑In addition to manufacturing industry, I would like to obtain certification for manufacturing and sales industry. 　
☑I would like advice in the field of in vitro diagnostic drugs.

Our support details

We handle services related to in vitro diagnostic drugs, focusing on the following services.

Manufacturing and sales license for in vitro diagnostic drugs ｜ Support for application to each prefecture
Manufacturer registration for in vitro diagnostic drugs | Support for application to each prefecture
Foreign Manufacturer Registration | Support for application to the Pharmaceuticals and Medical Devices Agency
Registration update/change application | Support for application to each prefecture
Manufacturing and marketing approval application | Support for applications to the Pharmaceuticals and Medical Devices Agency
QMS/GVP procedure creation and conformity review application | Support for applications to the Pharmaceuticals and Medical Devices Agency
Plan to obtain approval for in vitro diagnostic drugs ｜ Develop plans and budgets for obtaining approval and certification

Advantages of requesting our company

1. Specialist staff will assist you. 　

The sale of in vitro diagnostic reagents requires many licenses and permits. 　
It is difficult for busy business owners to properly interpret and implement laws that they are unfamiliar with.
As legal experts, we will reduce your burden.

2. Quick and reliable response

Our motto is fast response.
We will handle your various applications quickly and reliably on your behalf.

3. Consultation is free 　

We offer free consultation before placing an order.

Procedure flow

(1) General flow of approval stages for in vitro diagnostic drugs

① Consultation → Estimate First, please contact us by phone or through the inquiry form. After that, we will ask you to visit us once (or have a web interview) to confirm your current situation and provide you with advice. During the interview, we will listen in detail to your current situation and your wishes, confirm the requirements necessary for the application, and provide you with an estimate at a fair price. ② Application If you are satisfied with the amount presented in the estimate and the content of the service, please place an order. Please consult with the person in charge about the timing of payment of the fee and the success fee. ③ Collection of materials and preparation of documents We will prepare the requirements necessary for the application for manufacturing and sales business and manufacturing business. We will hold meetings with government agencies as appropriate regarding details such as manufacturing equipment and personnel requirements. In parallel, we will prepare the application documents and attached documents. *Our specialized staff will prepare the complete set of application documents and hold meetings with government agencies on behalf of the client. ④ Application agency Our administrative scrivener will apply on behalf of the client. The application fee will be collected before the application. If additional documents are requested, we will also handle it. ⑤ Examination An on-site inspection will be conducted during the examination. Our staff will also be present at the on-site inspection and take precautions in advance. If there are any instructions for correction due to missing or revised documents, we will handle it. The review period is approximately 2-3 months after the documents are accepted, if there are no problems. ⑥Notice of Permission If there are no problems after the review, you will receive a license. The license is valid for 5 years. ⑦Application procedures for each item Applications for manufacturing and sales approval and QMS conformity survey applications are submitted to a third-party organization or the Pharmaceuticals and Medical Devices Agency. *Application procedures are carried out on behalf of the client by specialized staff. ⑧Start of business Sales are possible once notification or approval has been received.

(2) General flow of approval stages for in vitro diagnostic drugs

General flow of approval stages for in vitro diagnostic drugs

Reference) Flow of manufacturing and sales industry

Nationwide Support

Applications for in vitro diagnostic drugs are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means! ! !

Contact form

Consultation content ※Required
(For corporations) Company name
Name ※Required
Furigana(Japanese Only)
E-mail address ※Required
Phone
Free initial consultation	Request an online interviewI would like to have an interview at the office.I don't want it now
Consultation office	TokyoNagoyaOsaka
Desired time for interview	MonthDay　Time ~*Please specify a time between 9am and 6pm on a weekday from two business days onwards.
Request intention ※Required	I would like to request it if the conditions are met.I would like to hear an explanation of the serviceI don't want to make a request right away, but I want to ask, etc.
How I learned about our company (Multiple answers allowed)	Newspaper advertisement (see media name below)Magazine advertising (see media name below)Web advertising (see media name below)taxi advertisingnotesLinkedInGeminiChatGPTClaudePerplexityOur YouTube channelYouTube channels other than ours (see below for channel names)FacebookXInstagrambilibiliWeChatRED (Xiaohongsho)TikTokGoogle Mapsauxiliary engineGoogle searchYahoo! SearchBing searchThreadsIntroduction (see the introducer below)Others (see below for details)

Terms of Use as well as the Privacy PolicyAfter agreeing to the contents of
Click the send button

*Please do not click more than 2 times.

*If the transmission fails, we apologize.this online formAlso try

Related article

© Support Gyoseishoshi Corporation

Free consultation available!

Free consultation available!