Product registration for Medical Devices
Summary of the Pharmaceutical Affairs Law (PAL) in Japan
To market medical devices in Japan, some basic requirements and regulations must be followed.
a) Definition of the term Medical Device
According to the PAL in Japan, 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).
b) 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).
c) 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).
d) 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).
e) 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)
- 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 (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.
