Manufacture and sell in vitro diagnostic drugs
Updated: July 2024, 10
Manufacture and sell in vitro diagnostic drugs
When manufacturing and selling in vitro diagnostic drugs, a manufacturing and sales license is required. Additionally, if you intend to continue manufacturing and selling the product beyond the expiry date of the license (5 years), you will need to renew the license.
Please note that products cannot be manufactured with this permission alone.
In order to manufacture products domestically and ship them to the market, both a manufacturing and sales business license and manufacturing business registration are required.
In addition, procedures such as approval, certification, notification, etc. for each product are required after obtaining a manufacturing and sales business license and manufacturing business registration.
(See below for manufacturing industry registration). Applications for manufacturing and sales business licenses must be submitted to each prefecture, but the requirements for submission vary depending on the local government. Submit it to the counter in each prefecture and get permission from the governor.
In the case of in vitro diagnostic drugs, the general manufacturing and sales manager in the manufacturing and sales industry must be a pharmacist.
Please note the personnel requirements.
Manufacturing and sales flow
Manufacture in vitro diagnostic drugs (domestic: manufacturer registration)
When manufacturing in-vitro diagnostic reagents, each manufacturing facility (limited to those that conduct the manufacturing process of in-vitro diagnostic reagents such as design, assembly, packaging, and other processes specified by Ordinance of the Ministry of Health, Labor and Welfare) must be registered as a manufacturer. is required.
Additionally, if you intend to continue manufacturing beyond the validity period (5 years) of registration, you will need to renew your registration.
With this registration alone, the product cannot be shipped to the market.
It is submitted to the counter in each prefecture and registered by the governor. This will be applied to each prefecture, but what you need to submit will vary depending on the local government. In the manufacturing industry, the responsible engineer and manufacturing manager must be a pharmacist.
Please note the personnel requirements.
Item procedures for in vitro diagnostic drugs
In order to distribute individual in vitro diagnostic drugs on the market, it is necessary to obtain the above permission and registration and then go through the approval procedures for each in vitro diagnostic drug.
It is necessary to apply to the National Agency for Compliance with the manufacturing control and quality control standards for in vitro diagnostic drugs and undergo an on-site inspection of QMS compliance.
For inquiries regarding approval and approval regarding in vitro diagnostic drugs, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting for everyone, from those newly entering the in vitro diagnostic drug industry to existing marketing distributors, manufacturers, and distributors.
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.
We provide legal services related to in vitro diagnostic drugs 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.
