Procedures for manufacturing, selling, importing and selling diagnostic image processing devices

Even if you search for medical device permission/approval, all the sites are government sites, so I think it's difficult to understand.

We often receive inquiries from people who do not know what procedures are required for the veterinary medical equipment they want to sell.

Support administrative scrivener corporationApproximately per year100More thanWe handle licensing and approval procedures for veterinary medical devices.

This site provides a summary of the necessary procedures even for first-time users.

If you read this articleProcedures for “diagnostic image processing device”You can now understand.
We hope you will understand the steps required before selling a "diagnostic image processing device."

What is a diagnostic image processing device?

Diagnostic image processing equipment is a general medical device and diagnostic device.

 

common name	Diagnostic image processing device
Definition	A device that processes transmitted X-rays and converts them into image information.
Classes	General medical equipment

Necessary procedures when manufacturing and selling diagnostic image processing devices in Japan

Manufacturer	Third-class veterinary medical equipment manufacturing and sales business
Domestic manufacturing factory	Veterinary medical equipment manufacturing industry registration
Wholesale store/Retail store	No formalities

Procedures required to import and sell diagnostic image processing equipment manufactured overseas in Japan

Import source	Third-class veterinary medical equipment manufacturing and sales business
overseas manufacturers	Foreign manufacturer registration for animal products
Domestic storage warehouse	Veterinary medical equipment manufacturing industry registration
Wholesale store/Retail store	No formalities

After performing the above procedure,
In order to distribute the product on the market as a medical device,
The manufacturer must submit a manufacturing and sales notification for veterinary medical devices in advance and obtain a manufacturing and sales notification number.
Even if diagnostic image processing equipment is manufactured overseas, notification must be made before importing it.

My Feelings, Then and Now

Here we have explained the procedures for selling <diagnostic image processing equipment> in Japan.
The key point is that different permissions are required depending on where the product is manufactured domestically and overseas.
In addition, in order to obtain veterinary medical device manufacturing and sales business license and veterinary medical device manufacturing business registration,
In addition to having a person in charge with an academic background, it is also necessary to prepare a management system called GMP.