Medical device manufacturing and sales industry, manufacturing industry, manufacturing and sales approval and certification

Electrical Appliance and Material Safety Law PSE mark

Updated: July 2025, 6


What exactly is PSE?

PSE certification is a certification based on the Electrical Appliance and Material Safety Law and certifies that electrical products meet Japanese safety standards.
PSE certification is necessary to guarantee the safety of electrical products, and PSE certification is required for electrical products used in Japan.
 
The legal basis consists of the following provisions:
 

The Electrical Appliances and Materials Safety Act aims to prevent dangers and injuries caused by electrical appliances by regulating the manufacture and sale of electrical appliances, as well as by promoting voluntary activities by private businesses to ensure the safety of electrical appliances.

Source: Electrical Appliance and Material Safety Law Article 1

The products regulated by this law (referred to as "electrical appliances") consist of 457 items specified by government ordinance. Of these, 116 items are designated as "specified electrical appliances" because they pose a serious risk of electric shock, fire, or other harm depending on their structure, usage, or other circumstances. (Article 2 of the Act)
 

Businesses that manufacture or import products that fall under "electrical appliances" (hereinafter referred to as "notifying business operators") must notify the Minister of Economy, Trade and Industry of the start of business (Article 3 of the Act), as well as technical standards. Businesses that have several obligations such as compliance obligations (Article 8 of the Act) and have fulfilled these obligations will be able to display the PSE mark as proof that they have carried out procedures based on the law. (Article 10 of the Act)
 

In addition, there are restrictions such as not being able to sell electrical appliances that are not labeled according to the law (Article 27 of the Act), and there are penalties for not following legal procedures, so they fall under the category of "electrical appliances". Appropriate procedures must be followed regarding products.

How much is subject to regulation?

The Electrical Appliance and Material Safety Law stipulates as follows.
 

Becomes a part of or is connected to general electrical facilities (meaning general electrical facilities as defined in Article 38, Paragraph 1 of the Electricity Business Law (Act No. 170 of 1963)) Machinery, equipment, or materials used for this purpose that are specified by Cabinet Order.
 
Portable generators specified by Cabinet Order
 
Storage batteries specified by Cabinet Order

 
Specifically, we have designated 457 items specified by the Electrical Appliance and Material Safety Law Enforcement Order (Cabinet Order) using a positive list method.
(Related to Article 2 of the Electrical Appliance and Material Safety Act, Appended Tables 1 and 2 of the Enforcement Order)

What is "PSE compliance inspection" and "PSE voluntary inspection"?

First of all, the main premise is that PSE is not something you have to obtain or get permission for.
Therefore, it is up to the business operator to determine whether the product in question is subject to PSE based on self-inspection.
In other words, it is the business operator's responsibility to make decisions and submit notifications.
 
Therefore, "PSE conformity inspection" and "PSE voluntary inspection".
First, as mentioned above, the PSE compliance inspection consists of inspecting and confirming the product itself and confirming the inspection equipment at the manufacturing factory.
All products for which PSE notification has been submitted must undergo voluntary inspection.
In this case, it can be said that "appearance inspection", "dielectric strength test", and "current conduction test" are essential.

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When manufacturing or importing electrical appliances, businesses must follow the procedures stipulated in the Electrical Appliance and Material Safety Act and display the PSE mark on the electrical appliances.
 

"Electrical appliances" here do not mean "products that use electricity."

"Electrical Appliances and Materials" refers to the products specified in the Electrical Appliance and Material Safety Law as follows.

  1. Machines, appliances, or materials used as part of or connected to general electrical facilities*, which are specified by Cabinet Order.

  2. Portable generators specified by Cabinet Order

  3.Storage batteries specified by Cabinet Order

 *Refers to general electrical facilities as stipulated in Article 38, Paragraph 1 of the Electricity Business Act (Act No. 170 of 1960)

Furthermore, under the Electrical Appliance and Material Safety Law, "electrical materials" can be divided into "specified electrical materials" and "specified electrical materials".

Specifically, a total of 116 items are designated as ``Electrical Appliances and Materials,'' including 341 ``Specified Electrical Appliances'' and 457 items other than ``Specified Electrical Appliances'' as specified by the Electrical Appliance and Material Safety Law Enforcement Order (Cabinet Order).

To determine whether or not to affix the PSE mark to a product, it is necessary to confirm whether the product is an "electrical appliance."

Referring to Attached Tables 1 and 2 of the Electrical Appliance and Material Safety Law Enforcement Order, if the purpose, function, structure, rating, and parts are not different from the name of the electrical appliance in the table, the product can be determined to be an "electrical appliance". !

*Even for the same product, the name of electrical appliances may differ depending on the purpose.
Therefore, legal procedures and required safety requirements vary depending on the usage.

Notes on the Medical Devices and Electrical Appliances and Materials Safety Act

For businesses that handle medical equipment, one thing to be concerned about is whether the medical equipment they handle is subject to the Electrical Appliance and Material Safety Act.

In the notification,

"DC power supply devices designed and manufactured for use as highly-regulated medical devices or as integrated controlled medical devices will be excluded from the scope of regulation under the Electrical Appliance and Material Safety Law."

Is stipulated.
(From the “Interpretation of the scope of electrical appliances” revised on January 27, 1)

In other words, medical devices subject to the Electrical Appliance and Material Safety Law are:

① DC power supply (ex. PC, smartphone)
②General medical equipment

may apply.

In other words, when handling these medical devices, it is necessary to check whether they fall under the Electrical Appliance and Material Safety Act.

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If you manufacture or import products that fall under "Electrical Appliances", you are required to follow the procedures below.

① Obligation to submit business start notification

② Obligation to comply with technical standards

③ Obligation to take a conformity test (specific electrical appliances only)

④ Obligation to conduct and record self-inspections

⑤ Display obligation

① Obligation to submit business start notification

If you are engaged in the manufacture or import of electrical appliances, you must notify the relevant Ministry of Economy, Trade and Industry within 30 days of the start of your business.
In this case, you will need to submit the statutory form, Form 1, "Electrical Appliance and Material Manufacturing (Import) Business Notification."
This notification must be submitted by group as defined by the Enforcement Regulations, not by category of electrical appliances, i.e., by product model (the notification has no expiration date, and if the content is similar to a notification submitted in the past, there is no need to resubmit it).

◎Notification of change in business notification matters

Electrical appliance importers are obligated to report without delay if there is a change in the following three matters, but this does not apply if only the name of the representative of the corporation is changed.

  • Name and address of importer
  • Type classification of imported electrical appliances
  • Name and location of the factory or workplace that manufactures the electrical appliances

◎Notification of discontinuation of electrical appliance import business

An electrical appliance importer must also submit a notification when it discontinues its business.
If there is no prospect of import business in the future, it is necessary to submit a notification of discontinuation of electrical appliance manufacturing (import) business.

② Obligation to comply with technical standards

The obligation to conform to technical standards means that the electrical appliances that the notifying business operator intends to manufacture or import must conform to the technical standards set out in the ministerial ordinance prescribing technical standards for electrical appliances.

There is a notice titled ``Interpretation of the Ministerial Ordinance Establishing Technical Standards for Electrical Appliances and Materials,'' which makes the above-mentioned Ministerial Ordinance more specific. ``If there is a technical basis that can ensure a sufficient security level in light of the ministerial ordinance, it will be deemed to be compliant with the ministerial ordinance.'' However, this interpretation is usually I think it will be necessary to comply with the technical standards specified in the attached table.

◎About standards

When importing electrical appliances, you must ensure that they comply with the technical standards stipulated by the Ordinance of the Ministry of Economy, Trade and Industry.
The technical standards for all electrical appliances are stipulated in the Technical Standards Ministerial Ordinance as ``Performance Regulations,'' and the interpretation of the ministerial ordinance that stipulates the technical standards for electrical appliances is referred to as the ``Technical Standards Ministerial Ordinance Interpretation.'' I am.
Even if a product complies with standards in another country, it does not necessarily mean that it complies with Japan's standards, so it is necessary to verify compliance with technical standards based on the Electrical Appliance and Material Safety Law.

◎Case where notification is not required

Confirmation of conformity to technical standards is not required in the following cases, but business notification is required in cases other than trial manufacturing and import.

  • When manufacturing or importing electrical appliances used for the following specific purposes, approval is obtained from the Minister of Economy, Trade and Industry.
    1. tourist model
    2. lithium ion storage battery
    3. antique lighting
    4. “Vintage” electric instruments
  • When manufacturing or importing on a trial basis.
  • Manufacture or import of electrical appliances exclusively for export by a reporting business

③ Obligation to take a conformity test (specific electrical appliances only)

Before selling electrical suppliesYou must undergo a conformity test by a registered testing organization (JET, etc.).

When manufacturing or importing specified electrical appliances, it is mandatory to undergo a conformity test and issue a certificate of conformity.


*The certificate of conformity has an expiration date. Even after you get it, make sure it hasn't expired.

④ Obligation to conduct and record self-inspections

Self-inspection is an inspection to confirm whether the product has been properly completed.

・For specified electrical appliances: manufacturing process inspection, finished product inspection, sample inspection

・Electrical appliances other than specified electrical appliances: Finished product inspection

During self-inspection, all manufactured products (one item at a time) are subject to inspection and recording.

The inspection record must include the following information:

Overview of electrical appliance items, type classification, structure, materials, and performance
Date and place of inspection
Name of person who conducted the test
Quantity of electrical appliances inspected
Inspection method
Test results

⑤ Display obligation

A notified business that has fulfilled its obligations under the law will display the PSE mark and the name of the notified business (and the abbreviation of the inspection agency in the case of specific electrical appliances).
If it is not labeled, it cannot be sold.

In order for a notifying business to sell electrical appliances, it is necessary to fulfill all of the above-mentioned obligations and label the electrical appliances in accordance with the method specified by the Ordinance of the Ministry of Economy, Trade and Industry.
  
The following items should be displayed:

  • Rated voltage, rated current, etc.
  • symbol
  • Notifying business name
  • Registered inspection agency name (for specified electrical appliances)

At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.

Applications for medical equipment and PSE certification require high levels of expertise, making it one of the few areas that administrative scriveners can handle.

We provide legal services related to medical devices based on the know-how and track record that can only be accumulated by administrative scriveners who apply to and negotiate with government authorities on a daily basis on behalf of companies.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.

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