Procedures for manufacturing, selling, importing and selling sanitary tampons and menstrual cups

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 “menstrual tampons and menstrual cups”You can now understand.
We hope you will understand the steps required before selling ``menstrual tampons and menstrual cups.''

What are menstrual tampons and menstrual cups?

Sanitary tampons and menstrual cups are class 1 medical devices and sanitary products.

 

common name	sanitary tampons
Definition	A filling made of cellulose or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal secretions, or a cup made of synthetic material that is inserted into the vaginal opening to collect menstrual or other vaginal secretions. This refers to stuffing. Some are scented or unscented for aesthetic or deodorizing purposes.
Classes	Ⅰ (General medical devices. Notification is required for each item before manufacturing and sales.)
QMS	Applicable

Necessary procedures when manufacturing and selling menstrual tampons and menstrual cups 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)

Necessary procedures when importing and selling sanitary tampons and menstrual cups manufactured overseas in Japan

The importer is a "Third-class medical device manufacturing and sales business".
For overseas manufacturers, "Foreign Manufacturer Registration" is required.
Domestic storage warehouses each require "Medical Device Manufacturing Industry Registration."

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 sanitary tampons and menstrual cups are manufactured overseas, notification must be made before importing them.

Summary

Here we have explained the procedures for selling <menstrual tampons/menstrual cups> 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.