When you set out to distribute a medical device in Japan, the procedure divides into three levels according to the device class. The same phrase — “handling medical devices” — can mean a licence, a notification, or no procedure at all, and which one applies changes both the lead time and the range of companies you can work with.
Three levels of distribution procedure
| Category | Class | Procedure for sale or lease |
|---|---|---|
| Highly-controlled medical device | Class III, IV | Licence (PMD Act Art. 39) |
| Controlled medical device | Class II | Notification (Art. 39-3) |
| General medical device | Class I | No procedure required |
In addition, a Class II device that also falls under specially-designated maintenance medical devices requires a licence rather than a notification. This covers devices where a failure to perform maintenance would affect diagnosis, treatment or prevention, or could endanger life.
Judging by class alone — “it is Class II, so a notification suffices” — misses the specially-designated maintenance category.
A licence and a notification are not the same weight
The words resemble each other; the practical burden does not.
A licence is granted following review. It must be obtained for each set of business premises, and a premises manager must be appointed, subject to requirements such as completion of prescribed basic training. It has a validity period and must be renewed.
A notification is filed once the requirements are met. A premises manager is likewise required, but there is no review process or validity period to manage.
This difference matters when choosing a counterparty. Only a company that already holds the licence can handle Class III and IV devices. Where the licence is yet to be obtained, the review and the work of putting the required systems in place land squarely on your project schedule.
“We have experience with medical devices” settles nothing
General medical devices in Class I require no distribution procedure at all. They can be handled without any licence or notification — gauze, adhesive plasters and certain medical gloves among them.
A statement that a company “has a track record in medical device distribution” therefore does not establish that it may handle Class III or IV. What settles the question is the licence certificate for the sale and lease of highly-controlled medical devices, not the track record.
Placing the product on the market is a separate procedure
Everything above concerns the party that distributes. Placing the product on the Japanese market requires a different procedure, which also divides by class.
- Approval … highly-controlled devices (Class III, IV) and Class II devices with no applicable standard
- Certification … controlled devices with an applicable certification standard (designated controlled medical devices, Class II). Issued by a registered certification body
- Notification … general medical devices (Class I)
The party that files for approval, certification or notification is the marketing authorization holder. Since an overseas corporation cannot obtain a Japanese marketing authorization in its own name, a domestic company must be designated.
Put together, selling an overseas medical device in Japan requires at least these three layers to be in place.
- The party responsible for placing it on the market (marketing authorization holder) — which files for approval, certification or notification
- Registration of the manufacturing site — overseas sites included
- The distributing company — holding the licence or notification matching the class
Order of work
The first thing to settle is which class the product falls into in Japan. The classification assigned in the country of export does not carry over. The same product sitting in different classes in different countries is not unusual.
Once the class is fixed, the required procedures and the qualifying conditions for a partner follow automatically. Proceeding with commercial discussions before the class is confirmed means the premise can shift after terms have been agreed.
INCAPE holds a licence for the sale and lease of highly-controlled medical devices (City of Osaka, No. 21N00270) and can handle devices including Classes III and IV. We advise from the classification stage onward.
