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Medical device certification for artificial insemination catheters

Posted: May 2020, 7

In Japan, the total population has been declining since peaking in 2008 due to the declining birthrate and aging population.

(From the Ministry of Internal Affairs and Communications “Information and Communications White Paper 30 Edition”).

In this era of population decline, the government is also formulating reform plans for social security.

The other day, I wrote about the draft interim report on social security reform for all generations, which will be compiled soon.

It was reported that the bill includes the expansion of insurance coverage for infertility treatment.

Our social security system is also changing with the times.

Here, we will highlight some of the medical devices for infertility treatment that have become a hot topic.

I would like to give you an overview of it.　

uterus for semen injection

The Ministry of Health, Labor and Welfare has designated uterine catheters for semen injection as Class I medical devices.

It is defined as shown in the table below.

common name	Uterine catheter for semen injection
Definition	A semi-rigid or rigid tube used to insert sperm into the uterus in intrauterine insemination procedures. This product is for single use.
Purpose of use or effect	Within the scope of definition (Yakushoku Machine Participant)1121First41No. Heisei26Years11Month21(“Matters to keep in mind when reporting the manufacturing and sales of medical devices”)
Classes	Ⅰ (General medical devices. Notification is required for each item before manufacturing and sales.)
QMS	Applicable

Verification and procedures regarding handling of uterine catheter for semen injection

If you are considering using a uterine catheter for semen injection,

is within the scope of the above definition, or

In addition, it is necessary to first verify two points: whether or not it falls under the category of "new medical device."

"New medical devices" are medical devices and structures that have already been approved for manufacture and sale;

Medical devices with clearly different usage methods, effects, or performance

(Pharmacy and Shokuhin No. 1120 No. 5, November 26, 11, “Application for manufacturing and sales approval of medical devices”)

If applicable, you will be asked to apply for approval.

If the device is determined to be a class I (general medical device) uterine catheter for semen injection after verification,

In order to distribute a product on the market as a medical device, it is the manufacturer's responsibility to submit a notification in advance.

You must set a 16-digit manufacturing and sales notification number.

Even if the uterine catheter for semen injection is manufactured overseas,

It is necessary to submit a notification before importing.

Please refer to this page for an overview of the notification of Class I devices.

https://

Furthermore, before applying for the above certification, the manufacturing factory, importing distributor, and storage factory must

It is also important to note that a medical device manufacturing and sales business license and medical device manufacturing business registration are required.

Permits required to manufacture and sell uterine catheters for semen injection in Japan

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

Permits required when importing and selling uterine catheters for semen injection manufactured overseas into Japan

Import distributor	Type 3 medical device manufacturing and sales business
Overseas manufacturing factory	Medical device foreign manufacturer registration
Domestic storage factory	Medical device manufacturing industry registration
Wholesale store/Retail store	No procedures (however, matters to be observed are in accordance with the Enforcement Regulations)178(as stipulated mutatis mutandis in the Article)

In order to obtain a medical device manufacturing and sales license and manufacturing industry 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, which is equivalent to ISO.

The system is quite difficult for new entrants.

At our company, for those who have difficulty obtaining permits,

We also arrange import agency services through licensed and authorized companies, so please feel free to contact us for more information.

Our medical device website can be found here.https://www.shigyo.co.jp/search_post/medical-cosmetics-liquor/iryo-kiki/

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