Manufacturing attention requirements
Updated: July 2024, 3
In 26, there was a major change in the construction law, and a comprehensive adjustment was made to meet the demands and release of requirements for manufacturing facilities.
Upon obtaining approval for the medical equipment manufacturing industry, on the basis of the applicant's demand and availability requirements, we will apply to the prefectural governor's acceptance site.
We will provide you with preparation and support for the on-site training session.
Acquisition manufacturing industrial requirements
| ① | Applicant (young person, legal person, person responsible for paying business) non-existent non-qualifying situation |
| ② | Responsible technical personnel configuration |
① Applicant (young person, legal entity, person in charge of the business) non-existence non-conformity
If you are a legal person (you are a legal person, you are an employee of a company that sells your business), the terms and conditions apply, and you are not eligible.
| ① | Article 75, Subsection 3 of the Medical Products, Medical Equipment, etc. Act, permissible cancellation and self-cancellation for a period of XNUMX years. |
| ② | The provisions of Article 75-3, Subsection XNUMX of the Medical Products, Medical Equipment, etc. Act, rescission subject to notice, and self-cancellation for a period of XNUMX years. |
| ③ | The defendant shall be sentenced to no less than 3 years of imprisonment, and the punishment shall be completed or suspended for XNUMX years after execution. |
| 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 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 |
②Designation of responsible technical personnel
Must be designated as one person in charge of engineering and manufacturing of medical equipment.
| medical instruments | Eligibility requirements | |
| Highly managed medical equipment management medical equipment | 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, completed work on quality management of medical products or medical equipment, and completed work on safety management after launch. Over 3 years. | |
| 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. | |
| General medicine equipment | 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. | |
Licensed medical equipment available, approval and approval etc.For your convenience, please contact 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.
