Persons responsible for licensing
Updated: July 2024, 9
Concurrently serves as general manufacturing and sales manager, domestic quality operations manager, management supervisor, and management manager.
It is possible to concurrently serve as general manufacturing and sales manager, domestic quality operations manager, management supervisor, and management manager in the following cases.
| <1> | The general manufacturing and sales manager can also serve as a management supervisor, manager, or domestic quality operations manager. |
| <2> | The domestic quality operations manager can also serve as the management manager. |
| <3> | The general manufacturing and sales manager may concurrently hold two or more positions with the management supervisor, manager, and domestic quality operations manager, as long as it does not interfere with the respective duties. |
Concurrently serves as General Manufacturing and Sales Manager, Domestic Quality Operations Manager, Safety Management Manager, and Responsible Engineer.
It is possible to concurrently serve as General Manufacturing and Sales Manager, Domestic Quality Operations Manager, Safety Management Manager, and Responsible Engineer in the following cases.
| Class 1 medical device manufacturer/seller | It is possible to concurrently serve as general manufacturing and sales manager and domestic quality operations manager. |
| Type 2 medical device manufacturer/seller | It is now possible to concurrently serve as the general manufacturing and sales manager and the domestic quality operations manager, and only in cases where the person is not concurrently serving as the domestic quality operations manager, the general manufacturing and sales manager and the safety management officer can also be held concurrently. Possible |
| Type 3 medical device manufacturer/seller | It is possible to concurrently serve as general manufacturing and sales manager, domestic quality operations manager, and safety management manager. |
| Domestic quality operations manager and responsible engineer | If the manufacturing facility is located in the same facility as the office where the business is conducted, it is possible to concurrently serve as the domestic quality operations manager and the responsible engineer. |
Requirements for general manufacturing and sales manager
| Medical equipment Manufacturing and sales business | Eligibility requirements |
| First class Type XNUMX | 1. Graduated from a university or technical college in a specialized course in physics, chemistry, biology, engineering, information science, metallurgy, electrical engineering, mechanics, pharmacy, medicine, or dentistry |
| ② Those who have completed a specialized course in physics, chemistry, biology, engineering, information science, metallurgy, electrical engineering, mechanics, pharmacy, medicine, or dentistry at a high school and have been engaged in the quality control or post-sales safety control of pharmaceuticals or medical devices for three years or more. | |
| 3) A person who has engaged in work related to the quality control or post-marketing safety control of pharmaceuticals or medical devices for more than five years and has completed a course conducted by an individual registered with the Minister of Health, Labour and Welfare. | |
| ④Those approved by the Minister of Health, Labour and Welfare | |
| Type XNUMX | 1. Those who have completed a specialized course in high school in the fields of physics, chemistry, biology, engineering, information science, metallurgy, electrical engineering, mechanics, pharmacy, medicine, or dentistry. |
| ②Those who have completed high school courses in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry, and have been engaged in work related to the quality control or post-sales safety control of pharmaceuticals, quasi-drugs, cosmetics, and medical devices for three or more years. | |
| 3) Those approved by the Minister of Health, Labour and Welfare |
Requirements for domestic quality operations manager
The Domestic Quality Operations Manager is the person in charge of quality control operations for medical devices, and is in charge of determining market shipments and processing recalls.
Quality control work requires knowledge and experience, so it is necessary to assign people with work experience.
A person who meets all of the following qualification requirements for the position of Domestic Quality Operations Manager can be appointed.
| ① | Be the person in charge of the quality assurance department at a manufacturer/seller |
| ② | Must have been engaged in quality control work or other similar work for 3 years or more |
| ③ | A person must have the ability to properly and smoothly carry out domestic quality control operations. |
| 4 | The applicant must not belong to a department related to the sale of medical devices, etc., and must not be at risk of interfering with the proper and smooth execution of domestic quality control operations. |
The QMS enforcement notice specifies the following as "(3) A person must have been engaged in quality control work or other similar work for three years or more."
"Persons who have been engaged in quality control work or similar work for three years or more" include the following persons in charge and those who have engaged in the work.
Furthermore, ``3 years or more'' may refer to the total number of years of relevant work, whether at your own company or another company.
a. Managers and supervisors
stomach. Chief administrator
cormorant. General manufacturing and sales manager for medical devices, etc.
workman. Quality assurance manager, manufacturing manager, and responsible engineer under the old law
O. Other marketing authorization holders or persons engaged in work related to manufacturing control or quality control in the manufacturing industry, etc.
mosquito. Continuous improvement or maintenance of the quality management system of businesses, etc. that have received ISO 9001 or ISO 13485 certification (limited to those that manufacture, sell, or manufacture products, excluding those that only provide services, etc.) person engaged in work
Safety management officer requirements
Qualification requirements for safety management personnel when manufacturing and selling highly controlled medical devices (class III/IV)
Those who meet all of the following conditions ① to ④ can be appointed.
| ① | Be the person in charge of the safety management department |
| ② | Must be a person who has been engaged in safety assurance work or other similar work for three years or more. |
| ③ | Must have the ability to properly and smoothly carry out safety assurance work. |
| 4 | The applicant must not belong to a department related to the sale of medical devices, and must not pose a risk of interfering with the proper and smooth execution of domestic security operations. |
Qualification requirements for safety management personnel when manufacturing and selling controlled medical devices (Class II) and general medical devices (Class I)
Those who meet all of the following ① and ② can be appointed.
| ① | Must have the ability to properly and smoothly carry out safety assurance work. |
| ② | The applicant must not be a member of a department related to the sale of medical devices, and must not otherwise pose a risk of interfering with the proper and smooth performance of safety assurance operations. |
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
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