For those who wish to sell endoscopic ultrasound diagnostic systems

What is an endoscopic ultrasound diagnosis system?

　The ultrasound endoscopic diagnostic system is a system for processing data obtained from ultrasound endoscopes and ultrasound imaging devices and using it for diagnosis. This system supports various sensors and application software packages used for further processing, display, and analysis of the obtained information.

　Typical applications consist of ultrasound transducers for specific software packages and peripherals and are widely used in diagnostics such as obstetrics and gynecology, gastrointestinal system, circulatory system, kidney, abdomen, heart, endoscopy etc. This device is classified as Class II.

Main functions

1. Data Acquisition: Obtain high-quality data from ultrasound endoscopes and ultrasound imaging devices.
2. Image processing: The acquired data is processed in real time to generate high-resolution images.
3. Analysis Function: The acquired data is analyzed in detail using dedicated diagnostic software.
4. Report Generation: Automatically generate a report summarizing diagnostic results and share it with the medical team.
5. Integration features: Works in conjunction with other medical devices and information systems to provide an integrated diagnostic environment.

When manufacturing and selling endoscopic ultrasound diagnostic systems domestically

Manufacturer registration: A Type 2 medical device manufacturing and sales license is required. (Type 1 may be required depending on the function.)　　　　　　　　　

Registration of domestic manufacturing plants: Registration as a medical device manufacturer is required.

Wholesale store/Retail store: If you are selling through B to C, you will need a sales license.

When importing and selling endoscopic ultrasound diagnostic systems from overseas

Importer RegistrationIf it is for human use, a Type 2 medical device manufacturing and sales license is required. (Type 1 may be required depending on the function.)　　　　　　　　　　

Registration of overseas manufacturers: Foreign Manufacturer Registration is required.

Domestic warehouse registration: Registration as a medical device manufacturer is required.

Wholesale store/Retail store: If you are selling through B to C, you will need a sales license.

After completing the above procedures, in order to distribute the product on the market as a medical device, the manufacturer must first submit a medical device manufacturing and sales notification and obtain a manufacturing and sales notification number. Even if the ultrasound endoscopic diagnosis system is manufactured overseas, the notification must be submitted before it can be imported.

Summary

Here we have explained the procedures for selling the Ultrasound Endoscopic Diagnostic System in Japan. It is important to note that different licenses are required depending on whether the product 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 a QMS.

　We provide consulting services to companies that want to handle medical devices. It can be harder than you think to enter the medical device business as a newcomer. We specialize in supporting start-up companies, so please feel free to contact us.

Furthermore, for those who find it difficult to obtain the necessary licenses and permits themselves, we also arrange for import agency services through licensed companies. By entrusting the necessary procedures to an import agency, it becomes possible to handle medical devices quickly and at minimal cost.