manufacturing sales permit request
Updated: July 2024, 3
The most important effect of medical equipment manufacturing and distribution in Japan.
Obtaining approval for medical equipment manufacturing is allowed, and on the basis of demand, the prefectural governor will apply for support, and the reception venue will be accepted.
We will provide full support for your request, preparation for the start of the process, assistance with on-site training, etc.
Acquisition manufacturing sales request
| ① | The claimant (as a result of the company's name, the customer's company name) does not exist. |
| ② | Manufacturer's installation |
| ③ | Management personnel arrangement |
| 4 | Management personnel configuration |
| ⑤ | Japanese quality industry personnel configuration |
| ⑥ | Safety management personnel configuration |
| ⑦ | Basic QMS system ministerial regulations, GVP ministerial regulations, quality management procedures, etc. |
①Applicant (As a result, it is a company's story, and the company's sales are similar to the company's work.) non-existence non-conformity situation
If the applicant is not satisfied with the offer (as a result of the company's name, the company's name is the company's name), and if there are any non-conforming circumstances, the person may not be able to receive the offer.
| ① | As defined in Article 75, Subsection XNUMX of the Nemoto Medical Equipment Act, permissible cancellation and self-cancellation for three years. |
| ② | The provisions of Article 75-3, Subsection XNUMX of the Nemoto Medical Products and Equipment Act, cancellation 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 the above-mentioned items ① to ③, any violation of the Medical Products, Medical Instruments, etc. Act, the Alcohol, Alcohol, and Mental Health Products Control Act, the Toxic and Hazardous Substances Control Act, and any other legal entity that may be responsible for the above-mentioned articles. ，And self-reported wrongful conduct in 2 years since birth. |
| ⑤ | A person who is an adult, or a person who possesses intoxicants, cannabis, or alcoholic beverages. |
| ⑥ | Ministry of Health, Labor and Welfare Ordinance Determined Causes of Mental or Physical Residual Disorders and Normal Development of Business |
②Manufacturer's configuration
The person responsible for the medical and equipment quality management and post-market safety management operations is in full demand.
| Medical equipment manufacturing business | Eligibility requirements | |
| The first Second | ① | Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, education, medicine, and medical trade courses at university or high school. |
| ② | Completed physics, chemistry, biology, engineering, informatics, metallurgy, electrical engineering, mechanics, geology, medicine or other industrial trade courses while in high school, and completed work on quality management of medical products or medical equipment or safety management after launch for 3 years. that's all. | |
| ③ | The quality control management of medical equipment or medical equipment has been carried out for more than 5 years after its launch, and the training and development of personnel has been completed by the Minister of Health, Labor and Welfare. | |
| 4 | Approved by the Minister of Health and Welfare. | |
| Third | ① | Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, biology, medicine, and industrial courses while in high school. |
| ② | While in high school, completed interrelated subjects such as physics, chemistry, biology, engineering, informatics, metallurgy, electrical engineering, mechanics, geography, medicine or other fields of medicine, as well as quality management of medical products, quasi-medical products, chemical products or medical equipment, and post-marketing. Over 3 years of experience in safety management. | |
| ③ | Approved by the Minister of Health and Welfare. | |
③Management personnel arrangement
Legal representatives and other personnel must have the highest level of independent management and oversight of the quality management system of the manufacturer.
④Management personnel arrangement
Among the manufacturing staff, managers, and other equivalent personnel, one person will be appointed to oversee the quality management system.
⑤Japan Quality Service Personnel Settings
The Japanese quality management industry is responsible for managing personnel, medical equipment, and equipment quality management, and has also decided on the management of personnel, equipment, and other matters.
Because of the quality management industry's demand knowledge and coordination, there is one person who is responsible for the demand leadership.
Japan quality industry operation personnel demand is below the requirements.
| ① | This is the manufacturer's quality assurance department. |
| ② | Over 3 years of product quality management or other similar work |
| ③ | Guaranteed Japanese quality management business normal business development ability |
| 4 | The absence of non-medical equipment, etc. personnel, and other possible obstacles to the normal development and development of Japanese quality control business. |
⑥Designation of safety management personnel
The person responsible for safety management is the person responsible for the safety management of medical equipment, and the person responsible for the safety management of the medical equipment collects the costs and collects the information regarding the safety of the medical equipment and the information that is reflected in the manufacturing of the medical equipment.
The qualification requirements for safety management personnel are below the qualification requirements for the position of homeroom teacher.
Qualification requirements for safety management personnel for manufacturing and control of highly controlled medical equipment (III, IV categories)
fullBelow ① to ④, the qualifications are as follows:
| ① | This is the person in charge of the body safety management department. |
| ② | 3 years or more of security work or other similar work |
| ③ | Safe and secure security operations, successful development capabilities |
| 4 | There are no non-medical personnel in the air control department, and there are no other possible obstacles to the normal development of Japan's security industry. |
Qualification requirements for safety management personnel for manufacturing and control medical equipment (Class II) and general medical equipment (Class I)
① and ② are below the qualifications for talent and qualifications.
| ① | Guaranteed security business normal wedding development ability |
| ② | The absence of non-medical personnel and other possible obstacles to the normal development of Japan's security industry. |
Licensed medical equipment available, permittedPlease acknowledge and agree with us.
We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.
Medical equipment application has high level of industry, ability is perfect, and administrative staff is small.
However, we provide medical equipment, medical equipment, legal services, and other legal services based on the basis of our production, business, and business agents.
Our teams are present in all prefectures across the country. You must receive additional information from our system.
