Medical equipment/cosmetics/pharmacies

In vitro diagnostic drug license approval

Updated: July 2026, 8

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!

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▼▽▼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 primarily handle the following tasks related to in vitro diagnostic medical devices.

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 Please contact us by phone or through the inquiry form. After that, we will ask you to visit our office (or have a web interview) to check your current situation and then provide advice. During the interview, we will listen carefully to your current situation and wishes, and after confirming the requirements necessary for the application, we will provide an estimate at a fair price. ② Application If you are satisfied with the amount and service details presented in the estimate, you can place an order. Please discuss the timing of payment of fees and success fees with the person in charge. ③ Document Collection and Preparation We will prepare the requirements necessary for manufacturing and sales business and manufacturing business applications. We will consult with administrative agencies as needed regarding details such as manufacturing equipment and personnel requirements. We will prepare the application documents and supporting documents in parallel. *Our expert staff will prepare all application documents and conduct consultations with administrative agencies on your behalf. ④ Application Assistance Our administrative scrivener will submit the application on your behalf. We will collect the application fee before submission. We will also handle any requests for additional documents. ⑤ Review An on-site inspection will be conducted during the review. Our staff will be present during the on-site inspection and will take preventative measures. If any corrections are requested due to missing or incorrect documents, we will handle them. The review period is approximately 2-3 months from the date the documents are received, provided there are no problems.⑥ Approval Notification If there are no problems as a result of the review, you will receive a license. The license is valid for 5 years.⑦ Application Procedures for Each Item We will submit applications for manufacturing and sales approval and QMS conformity assessment to a third-party organization or the Pharmaceuticals and Medical Devices Agency. *Our specialist staff will handle the application procedures on your behalf.⑧ Sales will be possible once the notification of commencement of business 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! ! !

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