Procedures for manufacturing, selling, importing and selling emergency bandages

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 “emergency bandaid”You can now understand.
We hope that you will understand the steps necessary before selling "Emergency Bandages."

What is an emergency bandage?

Emergency bandages are class 1 medical devices and sanitary supplies medical devices.

 

common name	emergency bandage
Definition	Refers to adhesive plasters of various shapes, such as cloth and plastic, that are used on parts of the body. Sometimes a pad is attached. Used for covering and protecting wounds, bonding skin to wounds, supporting wounded areas of the body, etc.
Classes	Ⅰ (General medical devices. Notification is required for each item before manufacturing and sales.)
QMS	Applicable

In order to manufacture and sell emergency bandages in Japan, the following procedures are required.

Procedures for manufacturing and selling emergency bandages in Japan

Manufacturer	Type 3 medical device manufacturing and sales business
Domestic manufacturing factory	Medical device manufacturing industry registration
Wholesale store/Retail store	No procedures (However, the matters to be observed are stipulated mutatis mutandis in Article 178 of the Enforcement Regulations)

Procedures for importing and selling emergency bandages manufactured overseas in Japan

Import source	Type 3 medical device manufacturing and sales business
overseas manufacturers	Foreign manufacturer registration
Domestic storage warehouse	Medical device manufacturing industry registration
Wholesale store/Retail store	No procedures (However, the matters to be observed are stipulated mutatis mutandis in Article 178 of the Enforcement Regulations)

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 emergency bandages are manufactured overseas, notification must be made before importing them.

Summary

Here we have explained the procedures for selling <emergency bandages> 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.