Procedures for importing and selling ultrasound diagnostic imaging devices

What is a general-purpose ultrasound imaging device?

A general-purpose ultrasound imaging diagnostic device is a general-purpose ultrasound diagnostic device designed for use in diagnostic imaging. It processes transmitted ultrasound and converts it into image information. This device is classified as Class II for human use, and is treated as a general medical device for veterinary use. It can be approved and certified by the Ministry of Agriculture, Forestry and Fisheries and the PMDA.

Procedures required for manufacturing and selling general-purpose ultrasound diagnostic imaging devices in Japan

1. Manufacturer registrationIf it is for human use, a Type 2 veterinary medical device manufacturing and sales license is required.
   　　　　　　　　　If it is for use in animals, a Type 3 veterinary medical device manufacturing and sales license is required.
2. Registration of domestic manufacturing plants: Registration as a medical device manufacturer is required. (Separate procedures for veterinary and human use)
3. Wholesale store/Retail store: If you are selling B to C, you need a sales license. (There are separate procedures for animal and human use.)

Procedures required when importing and selling general-purpose ultrasound imaging devices from overseas

1. Importer RegistrationIf it is for human use, a Type 2 veterinary medical device manufacturing and sales license is required.
   　　　　　　　　　If it is for use in animals, a Type 3 veterinary medical device manufacturing and sales license is required.
2. Registration of overseas manufacturers: Foreign manufacturer registration is required. (Separate procedures for veterinary and human use)
3. Domestic warehouse registration: Registration as a medical device manufacturer is required. (Separate procedures for veterinary and human use)
4. Wholesale store/Retail store: If you are selling B to C, you need a sales license. (There are separate procedures for animal and human use.)

After completing the above procedures, in order to distribute the product on the market as a medical device, the manufacturer must first obtain a medical device manufacturing and sales certification and obtain a manufacturing and sales certification number. Even if the product is a general-purpose ultrasound imaging diagnostic device manufactured overseas, it must be certified before it can be imported. (For veterinary use, a manufacturing and sales notification must be submitted.)

Summary

Here we have explained the procedures for selling a general-purpose ultrasound imaging device in Japan. The key point is that different licenses are required depending on whether the device is manufactured in Japan or overseas.

　In order to obtain a medical device manufacturing and sales license or a medical device manufacturing registration, it is necessary to secure a person in charge with an academic background, and to prepare a management system called QMS (GMP for veterinary use). We provide consulting services to companies that want to handle medical devices. Starting a new business in the veterinary medical device business can be more difficult than you might think. We specialize in supporting start-up companies, so please feel free to contact us.

In addition, for those who find it difficult to obtain the necessary licenses and permits in-house, we also arrange for licensed companies to act as import agents. By entrusting the necessary procedures to an import agent, it becomes possible to handle medical devices in a short period of time and with minimal costs.

Click here for our veterinary medical equipment sitehttps://www.shigyo.co.jp/search_post/medical-cosmetics-liquor/animalmd/