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【Certification Q&a(7)】We will respond to medical equipment, energy saving law, pse validity period, etc.

example Medical device Principles of authentication PSC PSE Q&A Radio Law
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Hello. It is a hori of the manager.

Are ○○ products eligible for certification without being investigated by ourselves? In principle, we do not answer vague inquiries, but of course, we have been investigated to some extent and answered questions about parts that we still do not understand.

If you have not been investigated, you will know that you are not willing to be certified in the first place, so we will not go out with it.

On the other hand, we will respond to customers' questions that they may not know whether or not they are eligible for certification due to problems of legal interpretation, based on our experience.

In fact, there seems to be a company that proposes unnecessary authentication because it is good that the customer does not know, and in particular, there was consultation from a person who had been interacting directly with an inspection organization in China.

We said that the inspection that the inspection organization is saying is definitely unnecessary on the basis, but it seemed to have been certified for the sake of the sake.

I left the final judgment there.

This "just in case" is a song person, and there is certainly a so-called gray zone one that a clear division is difficult to understand in the thing though it was certainly made without being conscious of a Japanese standard in China etc.

One way to do this later is to certify from the beginning, considering the risk costs that are said by ministries and agencies such as the Ministry of Economy, Trade and Industry and users (sauce comics).

On the other hand, there are many things that can be judged whether or not authentication is made by thoroughly examining the conditions in the text.

We propose authentication at the highest cost as reasonable as possible to our customers with the stance of not being wasted authentication as much as possible.

We also provide a service that asks the appropriate inspection authority to issue a certificate that the product does not require certification if it can be logically described as non-authentic.

Of course, there is no legal basis for that, but at least it proves that you are investigating and responding properly.

There are many things related to judgment on whether or not certification is possible, and examples are posted that have been directly confirmed by competent ministries and agencies.

However, since the views are divided for each product to the last, please be sure to check the contents of this time as it is, and if there is a similar example in your product, be sure to check it yourself.

Please note that we are not ultimately responsible for this content.

I would like to sell a smartwatch that measures body numbers such as blood pressure, but am I eligible for medical equipment?

In the first place, it is largely up to the business operator to decide whether or not it corresponds to a medical device.

In order to appeal that the product has a medical effect, certification of medical equipment is necessary, but if it is simply said that it massages and measures, it is not necessary to certify medical equipment.

On the other hand, those used in hospitals, etc. cannot be introduced without medical device certification.

The smartwatch that measures body numbers such as blood pressure, which we consulted this time, does not correspond to medical equipment from our point of view.

It is only for measured numerical reference only, and if the user feels an abnormality in the numerical value, it is necessary to re-measure it with the medical device sold by the medical device manufacturer again or go to the hospital.

So, when looking at the promotion page of the smartwatch, "This figure is a reference value, so if you feel something abnormal, please consult a medical institution", etc.

On the other hand, if you want to calculate really accurate numerical values with smartwatches and make medical data accurate enough, it is possible, but in order to meet the standards of medical devices, it is quite severe because you have to start by partnering with production manufacturers to raise production technology considerably.

Unless there is a reason to do it by all means, it is wiser to sell it without using it as a medical device.

I will write more about medical devices sooner or later.

In addition, most smartwatches are linked with smartphones, and at that time, radio law authentication is required, so authentication correspondence there is always possible, so please consult us if you like.

Is it possible to target PSE products produced just before the PSE expiration date?

The main premise is that with exceptions, pse is basically valid for five years.

For example, if the PSE expiration date is April 20, 2020, it is possible to target the original PSE for those that are produced before that and recorded production dates and other records and voluntary inspection records.

After 5 years of PSE certification, you may be unsure whether to re-certify the product.

If you are to authenticate in order to continue the product, it is basically necessary to authenticate from the beginning to a new certification, rather than the idea of additional authentication (which is cheaper).

In other words, since it will spend a reasonable authentication fee and certification period, it may be good to produce a little more just before the expiration date and decide whether to continue while watching its sales.

We plan to import and sell refrigerators, and the number of units produced will change whether or not they are subject to the Energy Conservation Act, how about it?

The Energy Conservation Act is under the jurisdiction of the Ministry of Economy, Trade and Industry and the Agency for Natural Resources and Energy, and is stipulated in the "Measures pertaining to Machinery and Equipment" of the Act on the Rational Use of Energy, etc.

Among them, the top runner standard is a mechanism that names products with the highest energy-saving performance as the top runner, and promotes the achievement of other products with the energy-saving performance of the top runner as the target value. As of 2018, air conditioners, electric refrigerators, electric freezers, LCD TVs, electric toilet seat, fluorescent lamp fixtures (home use) are covered.

When answering your questions, the Energy Conservation Act is the recommended certification in the first place. Just because you're not doing it doesn't mean you're not penalized.

If you are considering the number of production units depending on whether it is subject to certification, I think that you may not acquire the energy saving law from the beginning.

On the other hand, while major home appliance manufacturers are developing products (refrigerators) with energy-saving labels attached together, it is also a self-evident reason that if only one company does not have an energy-saving label, it will not be selected by users.

In addition, if you wholesale directly to the store for business use, I think that it is basically invisible to customers who visit the store, so certification may not be necessary.

However, in the future, it is said that it is only a company that considers the global environment such as the SDGs to survive, and it seems that there is an option to acquire certification with a little investment.

That point is a management decision, but when I go back to the first question, I think that certification is basically optional, so you can't worry about the number of production units.

The level of achievement of the target standard (top runner standard) to promote the improvement of energy-saving performance stipulated in the Energy Conservation Act is displayed on the label.


Energy-saving labels are displayed in easy-to-read places such as catalogs, product bodies, packaging, etc.
Citation: Ministry of Economy, Trade and Industry, Agency for Natural Resources and Energy_How to choose energy-saving home appliances

I do not want to display the radio law in the position where the product is visible in the design, operation, is it possible?

First, let's briefly explain the radio method display.

The size of the display must be at least 3 millimeters in diameter.
(Concept of the proposed amendment) The size of the display shall be only subject to identifiableness.

In addition, for the display itself of the Radio Act mark,
(1) Displayed on the main body. As an exception, in the case of difficulty in displaying on the main unit, it can be described in the instruction manual, packaging, or container.
(2) Electromagnetically recorded on the main unit and displayed on the display of the main unit.
Citation: Ministry of Internal Affairs and Communications Materials_Review of labeling methods for certification of compliance with technical standards, etc.

In short, it is basically better to display on the main body, but it is also allowed to describe it in other instruction manuals, packaging, containers, etc. due to product size and design (many irregularities, euphemisms, etc.).

Also, if the size of the display is identifiable, there is no limit.

In terms of (2), mobile phones are a prominent example.

This is speculation, but even if you check with the Ministry of Internal Affairs and Communications and the General Communications Bureau about how to display your products, it will be better to display them on the product if possible, but it is not illegal because it is in the package.

Ultimately, it is up to the operator to decide how to display it, and it seems that there is no problem if it is displayed firmly.

However, our view is that some products may be fried from other companies in the same industry.

(example)
"Illegal because it is not displayed on the product!"
→ is not actually illegal, but sns posting only that there is no indication on the product

In the sense of dispelling such a point from the beginning, I think that it is safe to display the product body because anything such as seal application is good.

In addition, there is an example described inside with the lid removed, not necessarily the surface of the product, so if it is difficult to display it on the surface by all means, please refer to such a thing as a reference.

Our wireless presenter: Radio law indication with a seal while removing the battery lid

Wireless mice of other companies in general distribution: Printing radio law marks on the battery lid

I certified the Bluetooth internal remote control to operate and operate the product by radio law, but the manufacturer has renewed without permission, is certification necessary again?

We will tell you on the assumption that the products to be operated are the same, that is, the built-in parts and specifications are the same.

Because of renewal, if the housing of the remote control changes and the model number has also changed, it will be necessary to rework.

However, depending on the condition of the change, it is possible to omit the inspection contents rather than completely new authentication.

In other words, the inspection cost is also expected to be somewhat cheaper than the initial cost.

However, basically, it will be done at the responsibility of the inspection body that performed the initial certification, so good communication with the inspection organization will be necessary.

In addition, the Chinese factory is often suddenly changed due to various circumstances, so please try to approach it on a daily basis, such as telling them to consult in advance in such a case.

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