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 article“Liquid bandage” procedureYou can now understand. I hope you will understand the steps necessary to sell "Liquid Bandage".
What is a liquid bandage?
Liquid bandages are class 1 medical devices and sanitary products medical devices.
If you are considering handling liquid bandages from now on, you will need to take the necessary steps to handle medical devices.
If this procedure is not followed, not only will it be a violation of the Pharmaceutical and Medical Devices Act, but if the product is from overseas, it will be stopped at customs.
The Ministry of Health, Labor and Welfare defines liquid bandages as follows.
common name
liquid bandage
Definition
A liquid, semi-liquid, or a combination of powder and liquid material used to protect or bond wounds on the skin or oral mucosa, or as a dressing for burns. However, when used on the oral mucosa, it is limited to temporary or short-term use.
Classes
Ⅰ (General medical devices. Notification is required for each item before manufacturing and sales.)
QMS
Applicable
Procedures for manufacturing and selling liquid bandages domestically
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 liquid 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 liquid bandages are manufactured overseas, notification must be made before importing them.
Summary
Here we have explained the procedures for selling <liquid 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.
We provide consulting services to companies that wish to handle medical equipment.
Entering the medical device business as a new company may be more difficult than you might think.
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 on their own,
We also arrange import agency services through licensed and authorized companies.
By outsourcing the necessary procedures to an import agency, we can handle medical devices in a short period of time and at the lowest possible cost.
