Private Import with Doctor’s license of unapproved medical devices

Legal background (As of September 3, 2014)

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 #0331003 – March 31 2005)

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 #0331003 – March 31 2005)

  1. For clinical trials
  2. For non-clinical tests/investigation
  3. As samples for display – not to be used for sales, promotion or advertising purposes
  4. For personal use – to be used directly by the importer. A prescription or written directive from a physician is necessary for such imports.
  5. For private import by a medical professional (doctor/dentist)

A medical doctor or dentist can import unapproved devices by presenting his/her doctor’s license. This is limited to cases where there is a clinical urgency and there are no alternatives in Japan. Additionally, the importer (doctor/dentist) must take all responsibility for the import and use of the device, and the device can only be used for the treatment or diagnosis of his/her own patients.

Private Import by a medical professional (doctor/dentist)

Application for Private importation

Once a Doctor (=Importer) import the unapproval products into Japan, he(she) must apply for permission to the MHLW . The documents required are;

  1. Importation form
  2. Precise description of the products
  3. Invoice
  4. Medical qualifications
  5. Statement of reasons (Certification of a clinical urgency and no alternatives in Japan)
  6. Air way bill

Promotion

  • 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

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.
A Doctor (=Importer) is allowed to obtain the brochures and/or the academic information materials of the product from Overseas Manufacturer, but not through the Import Support Agent.

The main steps in Private Import process are as follows:

  1. Purchase order and payment for the product including shipping:
    Importer → Overseas Manufacturer
  2. Legitimate product flow:
    Overseas Manufacturer → Customs clearance → Importer
    *It is unlawful for the product to be received by the importer through a domestic distributor or Import Support Agent.
  3. Obtaining Customs clearance approval from authorities:
    Import Support Agent can support a customs clearance submission documents on behalf of the importer.
  4. Payment for a commission for Import Support Agent:
    Importer → Import Support Agent

Installation and/or the Usage instruction of the product

  • 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.

Maintenance service and repair

  • The doctor (the importer) must repair the imported medical device by the importer himself.
  • The doctor (the importer) must import all the necessary repair parts privately using his/her own doctor’s license from the overseas manufacturer.
  • 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.
  • The Import Support Agent is prohibited to repair the product on behalf of the doctor’s (=the importer’s).
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