Manufacturing and sales license requirements
Updated: July 2025, 7
The medical device manufacturing and sales industry plays the most important role in distributing medical devices domestically.
In order to obtain a medical device manufacturing and sales license, you must meet the requirements, apply to the prefectural governor, and undergo an on-site inspection.
At Support Administrative Scrivener Corporation, we provide full support from the stage of preparing requirements to acting on your behalf in applying for permits and witnessing on-site inspections.
Requirements for obtaining a marketing license
| ① | The applicant (in the case of a corporation, the officer conducting the business) does not fall under any disqualification clause. |
| ② | Appointment of general manufacturing and sales manager |
| ③ | Assignment of management supervisor |
| 4 | Assignment of management personnel |
| ⑤ | Establishment of a person in charge of domestic quality operations |
| ⑥ | Assignment of safety manager |
| ⑦ | Procedures, etc. based on QMS system ministerial ordinance and GVP ministerial ordinance are in place. |
① The applicant (in the case of a corporation, the officer conducting the business) does not fall under any disqualification clause.
If the applicant (in the case of a corporation, the officer conducting the business) falls under the following disqualification clauses, permission will not be granted.
| Lee | A person whose license has been revoked pursuant to the provisions of Article 75, Paragraph 1 of the Pharmaceutical and Medical Device Act, and three years have not yet elapsed since the date of revocation. |
| Russia | A person whose registration has been canceled pursuant to the provisions of Article 75-2, Paragraph 1 of the Pharmaceutical and Medical Devices Act, and three years have not yet elapsed since the date of cancellation. |
| Ha | A person who has been sentenced to imprisonment with work or a severer punishment and for whom three years have not yet passed since the execution of the sentence has been completed or the person is no longer subject to the sentence. |
| D | In addition to those who fall under A to C, those who violate this Act, the Narcotic Drugs and Psychotropic Substances Control Act, the Poisonous and Deleterious Substances Control Act, and other laws and regulations related to pharmaceutical affairs specified by Cabinet Order or the disposition based thereon; A person for whom two years have not passed since the date of the act. |
| ホ | Adult wards or addicts to narcotics, cannabis, opium or stimulants |
| へ | Those specified by Ordinance of the Ministry of Health, Labor and Welfare as persons who are unable to perform their duties properly due to mental or physical disabilities. |
② Appointment of general manufacturing and sales manager
As the person responsible for overseeing the quality control and post-marketing safety management of medical devices, it is necessary to appoint a general marketing and sales manager who meets the following requirements.
| Medical equipment Manufacturing and sales business | Eligibility requirements |
| First class Type XNUMX | ① Graduated from a university or technical college in the fields of 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 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 |
③ Assignment of management supervisor
Officers such as the representative director must manage and supervise the quality control system-related operations of manufacturers and distributors at the highest level.
④Assignment of a manager
It is necessary to select a person responsible for implementing and maintaining the quality control and supervision system of a marketing authorization holder, etc. from among executives of the marketing authorization holder, persons in managerial positions, and other equivalent persons.
⑤Establishment of a person in charge of domestic quality operations
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. |
⑥ Assignment of safety management supervisor
The Safety Management Officer is the person responsible for the safety management of medical devices, and is responsible for collecting safety information regarding the medical devices they handle and reflecting it in the manufacturing of medical devices.
A person who satisfies all of the following qualification requirements for safety management officer can be appointed.
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.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
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.
