Manufacturing industry registration requirements
Updated: July 2024, 9
To manufacture medical devices in Japan, you must be registered as a medical device manufacturer.
Due to the revision of the Pharmaceutical Affairs Law in 2014, major changes have occurred, such as changing the scope of manufacturing facilities subject to registration and relaxing structural requirements.
In order to obtain medical device manufacturing industry registration, 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 to apply for registration and witnessing on-site inspections.
Requirements for obtaining manufacturing registration
| ① | The applicant (in the case of a corporation, the officer conducting the business) does not fall under any disqualification clause. |
| ② | Appointment of responsible engineer |
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| Lee | A person whose license has been revoked pursuant to the provisions of Article 75, Paragraph 1 of the Pharmaceutical and Medical Device Act, and three years have not yet elapsed since the date of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 responsible engineer
It is necessary to appoint a responsible engineer who will be responsible for manufacturing the medical device.
| handle Medical equipment | Eligibility requirements |
| Highly managed medical equipment managed medical equipment | 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 | |
| General medical equipment | 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 |
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.
