Q&A

Is beauty equipment or health equipment medical equipment? Is it possible to obtain demand?

Naturally, it is called beauty equipment or health equipment, but it is definitely a medical equipment, but it is a medical equipment. As a result, the equipment belongs to the medical equipment, the manufacturing industry is allowed to meet the demand, the manufacturing industry is allowed, and the product is approved or certified.

Is there any other medical equipment available in the country?

Immediately, there are other countries' medical equipment, it is not certain whether it matches Japanese standards, because of this, there are small equipment in Japan, and there is a new demand for Japanese equipment.

Medical equipment production, manufacturing, commercial and distribution center, independent storage, demand acquisition and sales are permitted. As a result, during the distribution process after the delivery of the goods to the shipping company, we will not be able to obtain any demand.

How to say "How to use health equipment, how to use medical equipment, how to use medical equipment", is this true?

As for the results of the use of the medical equipment, the specific effects or effectiveness of the medical equipment may be determined, the name may not be given, and the demand may be obtained.

Medical equipment manufacturing divisions I~III, medical equipment manufacturing divisions, many different categories of medical equipment, is it necessary to acquire each category?

If the result is obtained, it is allowed at the higher level, if it is not required, it is allowed at the lower level.

However, is the medical equipment currently available?

In the past, we have lost a lot of colored eyeglasses for viewing purposes.
However, due to the emergence of mass health problem reports, the demand for colored eyeglasses and ordinary eyeglasses has been obtained, and the "highly managed medical equipment sales" license is granted.

In addition, the Ministry of Health and Welfare's Ministry of Health and Welfare will inform you about the demand for eyeglasses at the time of your visit: check whether the consumer is attending a medical clinic, or if you are not yet employed by a doctor, provide health problem information to your doctor, make efforts to provide the appropriate products for use, and provide necessary information regarding the demand for the product you are using. After receiving the information, the consumer will be provided with information regarding the content of health issues and other information provided by the medical equipment prior to purchase, and will comply with the Health and Welfare Act.

Is there an attached document for the packaging and manufacturing process?

This is the manufacturing process for packaging.
Under the current circumstances, due to the fact that packaging is a part of the manufacturing industry, the manufacturing industry is focusing on meeting demand.

Are there any important points that can be updated?

In the current manufacturing industry, the new QMS system can be renewed, the demand can be confirmed, and the new QMS system has been established. The event was carried out locally.

Are there any important points that can be updated?

In the case of a change request.
The demand officer added the following documents: ``Changing the list of manufacturing process related items'' and ``Clearing the summary of the manufacturing facilities that can be changed separately''.

Is it okay for the person responsible for the production of the company to be the head of the company?

The person responsible for the production of the product is the person responsible for implementing the requirements of the production and production industry.
The company's long-term supervisor is in charge of the manufacturing costs, and the company's internal management issues are also important.

Is it okay for someone to pay for the production and to be able to serve concurrently?

The person responsible for manufacturing the product may also serve as a manager, manager, and person responsible for managing the Japanese domestic quality industry.
Under the premise that each person who is not present can be employed in the production industry, two or three people can serve concurrently.

Is it right or wrong? Is it possible for the person responsible for the production of the product to be completed?

We do not accept any responsibility for the agency's mediation. The construction will be used by Hello Work or other facilities to provide employment to employees who require employment.

In the future, overseas manufacturing facilities will begin producing medical equipment in Japan. Did you go abroad before the meeting?

The model name of the product has changed, is there a plan to move forward with the demand?

Under the circumstances of the complete change of name, the demand for new products and other items will be approved or approved.

Is there a QMS or GVP management guidebook, can I use it directly?

Inclusiveness in the mockup is the minimum requirement. Based on the basic requirements of many people, we can adjust the situation as the situation progresses.

ISO13485 is an international certification for quality assurance of medical equipment.
QMS ministerial ordinance is Japanese law (Medical Products, Medical Equipment, etc. Law) and standards for quality management of Chinese medical equipment.
ISO is an international standard, so when exporting products overseas, the requirements for obtaining ISO 13485 certification are required.

Other than medical extermination equipment, other products. Can other people be left in the same place?

However, medical equipment and other goods must be left in stock.

At the same time, Japanese sales are allowed. Is there a record of entry/exit records, etc.?

The manufacturing and sales industry is a different industry. Basically, it is a demand-separated construction book.

If you are a manufacturing company and you buy medical equipment, is it possible for you to acquire a store under the current circumstances?

Highly managed medical equipment or specific maintenance managed medical equipment, each one of which can be purchased according to the city's demand.
In this country, we manage medical equipment, and each and every one of them is designed for demand.
General medical equipment, non-essential equipment available.

Is it long enough for highly managed medical equipment etc. to be available for purchase in the industry?

Effective period: 6 years. Details of the progress update procedure that can be obtained.

Can I manage my own company's medical equipment and other company's warehouses?

Persons who are unable to purchase or sell their products are allowed to manage their operations.
Must be able to obtain (proposal).

Is the product on display at the exhibition or the exhibition acceptable?

The exhibition hall is a single industry location, can be used immediately, and can also be used for demand acquisition.
The purpose of the exhibition, the existence of the exhibition, etc., the permission to obtain the demand, etc.
However, the result is that the products are displayed in a row, and the venue's recent music venue management is managed, and unnecessary items are allowed.

Do you have medical equipment repair industry?

Medical equipment can be repaired in areas such as malfunction, damage, deterioration, etc., and can be used to repair the original situation.
Necessary supplies, replacement and deterioration of zero parts also belong to repair equipment, however, there is no need for maintenance of replacement consumables, etc., and there is no repair equipment available.

What is the content of the "Summary of the Purpose of the Product" included in the "Product Purpose Summary" for the manufacturing price?

1. Product purpose overview
2. Approval standard compatibility etc.
3. Japanese-style medical equipment comparison
4. Usage situation in foreign countries


Details: Points of reference

Is it possible to approve the manufacturing of medical equipment under the circumstances?

〇It is possible to proceed with medical equipment and equipment.
1. The person who obtained the approval, the person who received the approval, or the situation of the combination.
2. The person who obtained the approval, the person who gave the approval, the status and purpose of the person who gave the approval, the quality of the medical product, the effectiveness, the safety, the mutual ownership, and the information information.
Details: Points of reference

萬说 MEDICINE DIVISION MANAGEMENT MEETING PLEASE PLEASE PLEASE CONTINUE TO EDUCATE THE CULTURE CONFERENCE.

Each prefecture's local government affairs department will conduct a research conference on the local government affairs department.
Information about the exchange is available at the exchange terminal. During the training session, it is possible to participate in the training session.

Comparative information regarding the use of our medical equipment and equipment.

In order to obtain approval or approval for use in class II or above, separate medical equipment must be protected for use within the facility, and the equipment must be protected for use.
Medical equipment maintenance costs, immediate material costs, and the following types:

1. Includes technical equipment, free of charge
⇒Medical equipment commonly used in hospitals such as MRI, CT, super voice manual instruments, manual tools, syringes, etc.
2. Excluded from manual use, special medical equipment, individually designed materials for each function, possible to proceed with withdrawal of "specified health care materials"
⇒ Primary triggers, guide tubes, orthopedic materials, dental materials, etc. that are consumable during each hospital treatment or treatment

After the manufacturer's license is approved, the medical policy bureau for demand management will submit a request for insurance coverage.