repair medical equipment
Updated: July 2024, 3
The business of medical equipment repair work is general medical equipment repair work, damage to medical equipment, replacement or modification of parts to original conditions (comprehensive replacement is minor parts).
Due to the current unavailability of the product, we are currently in the process of repairing aging parts and other parts that may need to be replaced.
Maintenance, maintenance, certification, replacement consumable parts, etc., non-inclusive repair work, and non-essential repair work are also permitted.
Our medical equipment manufacturer repairs and self-manufactured medical equipment, and non-essential repairs are permitted.
However, if the medical equipment is not required, the medical equipment, etc., may be covered by the medical equipment, but if the medical equipment is not required, the safety of the medical equipment, etc. may be compromised.
Desired to open repair industry company, required to obtain the required workplace.
| demand permitting circumstances | unnecessary circumstances |
| ・Repair of our medical equipment (excluding company-owned products). - On-site repair of medical equipment, etc. (excluding company-owned products). ・Joint construction and repair of medical equipment (excluding company-owned products). (When the repair company is responsible for the repair). | ・Due medical equipment manufacturer (inclusive design or independent product manufacturing business) Manufacturer of medical equipment equipment and equipment manufacturer. ・Considerations such as cleanliness, academic qualifications, change conditions, etc. ・Just a minor specialist. |
Repair classification
9th category, 1st category to 9th category.
The nine categories are divided into two categories: “Specified insurance medical equipment (specially managed)” and “Non-specified insurance medical equipment (non-specially managed)”.
Immediately available for immediate use, non-specific medical equipment that cannot be repaired, must be available at the same time for both separate categories.
Specified health care medical equipment
Special category 1: Prospective decision-making system related matter
Special category 2: The amount of money and the physiological system that exists.
Special category 3: Equipment for Japanese machinery used in Yojitsu.
Special Category 4: Human-made organs
Special Category 5: Optical Instruments
Special category 6: Equipment and equipment
Special category 7: Medical equipment management
Special category 8: Equipment for playing in the playing room
Special category 9: Steel-based equipment Japanese home medical equipment
*Currently, for non-use purposes
Non-specific health care medical equipment
Non-Special Category 1: Approval, determination, and development system related matters
Non-Special Category 2: The amount of money invested and the physiological phenomena that exist.
Non-Special Category 3: Equipment for Japanese machinery used in Yojitsu
Non-Special Category 4: Human-made organs
Non-Special Category 5: Optical Instruments
Non-Special Control Category 6: Control Equipment
Non-Special Category 7: Medical Equipment Management
Non-special category 8: Equipment for playing in the playing room
Non-special category 9: Steel-based equipment Japanese home medical equipment
Repair industry permit requirements
Required repair is allowed, the following three standards are required.
(1) Installation required for development and repair work.
(2) The petitioner (as a matter of fact, the company's name, the company's company's name, and the comprehensive price of the company's business) are required to meet the specific requirements of the terms and conditions.
(3) An appointed engineer.
① Development and repair work must be carried out in accordance with the specifications.
The following specifications must be complied with for development and repair work (Ministry of Health and Welfare Ordinance No. 36, February 2, 1).
| 1 | It is a safe and sustainable method to maintain zero parts and make necessary medical equipment adjustments after repair. |
| 2 | We will provide you with the necessary equipment to proceed with the examination and testing of the medical equipment after repairing the different types of medical equipment that you will be provided with. However, if you do not use the above-mentioned test, you may not be able to use the machine, or you may not be able to use the machine. Well. |
| 3 | We have the necessary equipment for ongoing repair. |
| 4 | The following conditions apply in the case of ongoing repair. (a) The lighting is light, the light is light and the wind is clear, and the light is clean. (b) Clear and clear area of daily address. (c) Existing intrusive area. (d) Installation of shelters, tide protection, insect control, etc. However, if the medical equipment is not tested for failure or malfunction, please refer to this specification. (e) Wooden boards for baseboard construction, mixed clay or similar materials. However, if the medical equipment has been properly repaired, it should not be subject to any malfunction under certain circumstances. (f) The provision or provision of water supply facilities for demand. |
| 5 | The workbench provided within the workshop is important to ensure that the production process is easy and convenient. |
②The petitioner (as a matter of fact, the company's name is the company's name, the comprehensive discount is applicable to the company's business) must be in accordance with the terms and conditions of the terms and conditions.
In accordance with Article 5, Section 3 of the Act on Medical Equipment, Equipment, etc., if any item fails, it may be possible to obtain it.
| 1 | Article 75, Subsection XNUMX, permissible cancellation and self-cancellation for three years. |
| 2 | The provisions of Article 75-3, Subsection XNUMX of Neti, rescission subject to notice, and self-cancellation for XNUMX years. |
| 3 | The defendant shall be sentenced to no less than 30 years' imprisonment, and the punishment shall be completed or suspended for three years. |
| 4 | Except for items 1 to 3 above, any person who is responsible for any violation of the Medical Products, Medical Equipment, etc. Act, the Alcohol, Alcohol, and Mental Health Materials Control Act, the Toxic and Harmful Substances Control Act, and any other legal entity that may be responsible for such products. ，And it's been 2 years since the birth of the wrong law. |
| 5 | A person who is an adult, or a person who possesses intoxicants, cannabis, or alcoholic beverages. |
| 6 | The Ministry of Health, Labor and Welfare's regulations determine the normal development of medical equipment and equipment repair work without mental or physical residual disease. |
③ Appointment of one designated engineer.
Special maintenance management medical equipment repair worker
Persons who have been in the field of medical equipment repair for more than 3 years, and who have completed the basic training course and have completed the basic training course of the staff in charge of the Ministry of Health, Labor and Welfare, and who have worked in the field of medical equipment repair for more than 188 years.Article 1, Subsection 1, Section XNUMXA ).
The Minister of Health, Labor and Welfare has approved a person who is equivalent to the person who has the knowledge of the section A in Section A (《实行规则》Article 188, Subsection 1, Section 1 B).
(1) Special category XNUMX
Participating members of the Japan Radiology Industry Association's medical radiology equipment technology team (1st to 9th term).
(2) Special category XNUMX
Passed the Japanese Society of Biomedical Engineering's 2nd category ME technology ability examination (1st period to 17th period).
Non-specified maintenance management medical equipment repair operator
Persons who have been in the field of medical equipment repair for three years or more and who have completed the basic training course at the Ministry of Health, Labor and Welfare (Article 3, Subsection 188, Section 1 A).
Licenses and medical equipment are available, approved and approved by us.
We welcome new medical equipment businesses and existing manufacturing companies, production companies, Japanese medical equipment businesses, and other companies that offer Japanese medical equipment, etc., and support Japanese legal filings.
Medical equipment applications have a high level of industry, and their capabilities are perfect, but their trivial work is less than that of an administrative administrator.
We have a number of companies in Japan that are owned by prefectures. I have to pay for the service.以Get more information.
