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Private Import with Doctor’s license of unapproved medical devices
Legal background (As of November 1st, 2024)
Summary of the Pharmaceutical Affairs Law (PAL) in Japan
To market medical devices in Japan, some basic requirements and regulations must be followed.
Definition of the term Medical Device
According to the PAL, medical devices are defined as “equipment/devices etc. specified by the government ordinance that are intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the human or animal body” (PAL Article 2).
Requirements for Approval
Medical devices that are not approved or certified may not be imported into Japan for the purpose of sales. It is also prohibited to sell, lease, give or lend unapproved medical devices. Additionally, unapproved devices may not be manufactured, imported, stored or exhibited for the purpose of sale, lease, free gift or rental (PAL Article 65).
Requirements for Licensing
Any importer, distributor and/or sub-distributor of medical devices must obtain the appropriate license from the authorities in order to sell such devices within Japan. To obtain the license, they are required to hire managing personnel with the appropriate qualifications as full-time employees (PAL Article 12).
Those who engage in the business of repair, service or maintenance of medical devices must obtain the appropriate license from the authorities. To do this, they must hire managing personnel with the appropriate qualifications as full-time employees (PAL Article 40).
Requirements for Advertising Regulations
It is prohibited to advertise the names, manufacturing methods, indications and effect or performance of medical devices or to engage in promotional activities if the devices are not approved or certified (PAL Article 68).
Requirements for Medical Device Import
The competent authorities allow the import of unapproved medical devices only in specific cases. There are five main categories where such importation is allowed. In each case, review and approval by the Pharmaceutical Inspector at the Regional Bureau of Health and Welfare is required. Such importation is allowed in only the following situations: (Notification by the Director-General of the Pharmaceutical and Food Safety Bureau in MHLW #0628-4 – Jun 28 2024)
The competent authorities allow the import of unapproved medical devices only in specific cases. There are five main categories where such importation is allowed. In each case, review and approval by the Pharmaceutical Inspector at the Regional Bureau of Health and Welfare is required. Such importation is allowed in only the following situations:(Notification by the Director-General of the Pharmaceutical and Food Safety Bureau in MHLW #0628-4 – Jun 28 2024)
- For clinical trials
- For non-clinical tests/investigation
- As samples for display – not to be used for sales, promotion or advertising purposes
- For personal use – to be used directly by the importer. A prescription or written directive from a physician is necessary for such imports.
- For private import by a medical professional (physician/dentist)
- There is a clinical urgency.
- There are no alternatives in Japan.
- The importer (physician/dentist) has to take all responsibility for the import and use of the device.
- The device can only be used for the treatment or diagnosis of importer's patients.
- The importer (physician/dentist) will have to make repairs.
- Importation form
- Precise description of the products
- Invoice
- Medical qualifications
- Statement of reasons (Certification of a clinical urgency and no alternatives in Japan that explains also the reasons why the treatment is necessary and states that the medical professional who imported the device will take full responsibility for its use only on their own patients.)
- Air way bill
- According to the Pharmaceutical Affairs Law (PAL), it is prohibited for anybody to do any promotional process and promotional activity in Japan for the non-approved medical devices/drugs.
- At the academic meetings and/or the exhibitions, any organizations or persons, even if they or he attends from oversea, who are directly involved with the sales of the product are not allowed any advertisement and promotion of unapproved product with its name, method of manufacturing, performance and effect-efficacy.
- It is prohibited to sell, lend and give any unapproved medical devices regardless of whether or not compensation is received.
- Private import by using Doctor’s license is legally allowed with certain conditions. However, those “conditions” are subject to change by the authorities without any advance notice.
- The doctor (=the importer) is allowed to obtain the brochures and/or the academic information materials of the product from the overseas manufacturer, but not through the Import Support Agent.
- The Import Support Agent can perform only an import action in place of the doctor. (=the importer).
- The money flow is: Doctor (the importer) → The overseas manufacturer.
- The legal shipment flow of the product is: The overseas manufacturer → The doctor (The importer)
- The commission for the Import Support Agent is: The overseas manufacturer → The Import Support Agent
- The overseas manufacturer is prohibited to conduct the installation and/or the usage instruction of the unapproved product in Japan.
- The overseas manufacturer is prohibited to do the Usage instruction, in Japan, of the product to the other doctors etc. who are not the importer.
- The Import Support Agent is prohibited to install the product on behalf of the overseas manufacturer.
- The Import Support Agent is prohibited to do the usage instruction of the product on behalf of the overseas manufacturer.
- The Import Support Agent is allowed to install the product at the doctor’s (=the importer’s) request and at the doctor’s own risk.
- The doctor (the importer) must import all the necessary repair parts privately using his/her own doctor’s license from the overseas manufacturer.
- Basically, the physician (importer) must repair the product themselves.
- The overseas manufacturer is allowed to send the engineer(S) from the overseas to Japan for the maintenance and the repair of the unapproved product. However, in that case, it is prohibited for the engineer(s) to bring any repair parts with him into Japan.
- The Import Support Agent is prohibited to repair the product on behalf of the overseas manufacturer.
A medical physician or dentist can import unapproved devices by presenting his/her doctor’s license. This is limited to following all cases.
Private Import by a medical professional (physician/dentist)
Application for private importation
Once the Importer (=the doctor) import the unapproval products into Japan, he(she) must apply for permission to the MHLW . The documents required are;
