Procedures for manufacturing, selling, importing and selling flow-type clinical chemistry analyzers

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 medical devices they want to sell.

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

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

If you read this articleProcedures for “Flow Method Clinical Chemistry Analyzer”You can now understand.
We hope that you will understand the steps necessary to sell the "Flow Method Clinical Chemistry Analyzer".

What is a flow-type clinical chemistry analyzer?

The flow-type clinical chemistry analyzer is a class 1 medical device analyzer.

 

common name	Flow type clinical chemistry analyzer
Definition	Automatic or semi-automatic equipment used for qualitative and quantitative analysis of chemical substances and human tissue samples. In this device, chemical reactions occur in a continuous fluid flow. Samples are removed from the sample cup in the turntable at set intervals and guided into the reagent stream. The protein is separated from the analyte by dialysis through a semipermeable membrane. Fluid movement is created by a peristaltic pump, moving reagents and samples within the tube. Excluding mobile ones.
Classes	Ⅰ (General medical devices. Notification is required for each item before manufacturing and sales.)
Special maintenance management medical equipment	Applicable

Procedures for manufacturing and selling flow-type clinical chemistry analyzers in Japan

Manufacturer	Type 3 medical device manufacturing and sales business
Domestic manufacturing factory	Medical device manufacturing industry registration
Wholesaler/Retailer	Highly controlled medical device sales business license (for specified maintenance controlled medical devices)

Procedures for importing and selling flow-type clinical chemistry analyzers manufactured overseas into Japan

Import source	Type 3 medical device manufacturing and sales business
overseas manufacturers	Foreign manufacturer registration
Domestic storage warehouse	Medical device manufacturing industry registration
Wholesaler/Retailer	Highly controlled medical device sales business license (for specified maintenance controlled medical devices)

After performing the above procedure,
In order to distribute the product on the market as a medical device,
The manufacturer must submit a medical device manufacturing and sales notification in advance.
You must set a 16-digit manufacturing and sales notification number.
Even if a flow-type clinical chemistry analyzer is manufactured overseas, it is necessary to submit a notification before importing it.

Summary

Here, we have explained the procedures for selling a flow-type clinical chemistry analyzer 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 a medical device manufacturing and sales business license and manufacturing business registration,
It is necessary to secure a responsible person with academic background and experience in quality assurance work, etc.
It is necessary to prepare a management system called Quality Management System that is equivalent to ISO.