Are sex-toys categorized as Medical Device in Japan?
mogu@oggo.jp
[bogo]
-Digest
- It's not era to hide "sex things" anymore. It's great to that the sex toy industry is booming in Japan.
- By the way, In Japan, there is a classification called "medical equipment", and if a product falls under this category, procedures are required.
- Well, then, could sex-toys be categorized as a Medical Device?
- Summary
Let's begin.
1.It's not era to hide "sex things" anymore. It's great to that the sex toy industry is booming in Japan.
Sex toys are items that used for getting the sexual pleasure and called "Pleasure toys", "Adult toys" or etc..
It has become easier to obtain it with the spread of the internet.
There are some of them that have designs that even fit into the interior.
I feel the industry has not been underground, it has a positive impression of enjoying sexuality.
2.By the way, In Japan, there is a classification called "medical equipment", and if a product falls under this category, procedures are required.
OK, let me go off on a tangent and write about "Medical Device". I will make ends meet.
- To manufacture/ sell/ distribute some kind of product that is categorized into product categories that are listed up on PMD Act. in Japan include this "Medical Device" the company has to obtain required licences and authorizations.
- When the product meets the conditions, the product will be categorized as a Medical Device kind of automatically. It's like being legally an adult when you're 18 years old.
When you hear the word "Medical Device", you feel that it is a device for medical use, that is, a "doctor's tool". But this is only a part of Medical Device. There might be some Medical Devices even in your house such as thermometers and massage machines, which are actually medical devices.
医療機器の定義
"Medical Device" has been defined by "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Hereinafter referred to as Yakki-hou, because it's too long).
(4) The term "medical device" as used in this Act refers to appliances or instruments, etc. which are intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure or functioning of the bodies of humans or animals (excluding regenerative medicine products), and which are specified by Cabinet Order.
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Article2
It's really hard to understand! Let me explain it with a Venn diagram.
Much better.
3.Well, then, could sex-toys be categorized as a Medical Device?
The problem is whether sex toys meet "A∩B∩C" or not.
Let me write over it.
Sorry for my messy handwriting. Let's check the conditions one-by-one.
A【Target of Use】is human or animals
Yes, right?
B【Intention】meets 1 or 2 of below
1: for use in the diagnosis, treatment or prevention of disease
2: to affect the structure or functioning of the bodies
This is a condition we can't tell generally. It depends on the product.
But if the product is the one for the purpose like I list up below, the product will meets this condition.
- treatment of frigidity and ED
- Vaginal dilation
- Vaginal cleansing
- Pelvic floor muscle training
This is just an extra, but you should also pay attention to the following expressions.
- Wound healing, trouble sedation: Pharmaceuticals
- Skin whitening: Quasi-drugs
- Moisturizes the skin: Cosmetics
（Related past topic: The regulations surrounding "Personal Lubricant" in Japan）
C being specified by【Cabinet order】
Yakki-hou, the Act that has a long name, has an enforcement order and we can see the cabinet order is in it.
There are some names that can be related sex toy.
I pick up some of them for understanding. It says vibrator（バイブレーター）, condom（コンドーム）, contraceptive tools（避妊具） and sex tool（性具）.
OK. What is "sex tool". Actually the court has given a definition of "sex tool".
薬事法施行令別表第一に掲げる「性具」とは、人が性交若しくは性交類似行為(自慰を含む)に際し性感の刺激、増進ないし満足のために性器に付着あるいは接触させて使用することを目的とする器具をいうものと解するのが相当である。
<google translate>
[3]東京高裁昭和50年11月25日判決（刑集第28巻4号465頁）
"Sex toys" listed in Appendix 1 of the Pharmaceutical Affairs Law Enforcement Ordinance means that a person uses or attaches to or contacts the genitals for stimulating, promoting or satisfying sexual feeling during sexual intercourse or sexual intercourse-like acts (including masturbation). It is reasonable to understand that it refers to the target instrument.
I think the court had a same image on the word "sex tool / sex toys" as general people would have.
Summery
Conclusion: Sex toy can be categorized as a medical device in Japan and it's depends on the product.
There is a wide variety of sex toys, so it's impossible to conclude all at once.
As I wrote at the beginning, the sex toy industry in Japan is big and becoming open.
But keep in mind that legal regulations will follow the growing industry.
In the Japanese sex toy industry, there are still many areas where the application of the law is ambiguous, and many companies are doing business in this ambiguous area. However, it is wise not to assume that this situation will last forever.
(related past topix: "Training device for Pelvic floor muscles" as MD in Japan has been established")
If that happens, "I'm sorry I didn't know" will not work. Specifically, you can be arrested and/or surcharged.
Oggo.jp
Start by understanding the status quo to reduce future business risk.
If you don't know how to do it, please feel free to contact Oggo.jp.
It is possible to collect certain information without giving your company's name to the government
Refferance
- "薬事法の一部を改正する法律（平成25年6月14日法律第69号）"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000045726.html
- "薬事法及び採血及び供血あつせん業取締法の一部を改正する法律（平成１４年法律第９６号）参考資料". 厚生労働省 . https://www.mhlw.go.jp/topics/2002/09/tp0910-2.html
- "東京高裁昭和50年11月25日判決（刑集第28巻4号465頁）". https://www.courts.go.jp/app/hanrei_jp/detail3?id=20538
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