Hello Jim
RAPS has an excellent book that came out a couple of years ago on Japan regulations....I highly recommend that you get it to give you the basic info. It costs about $200.
The personal importation into Japan is exactly as it sounds....
The phyisician must purchase from a company OUTSIDE of Japan. No transaction or money exchange can happen with an Japanese entity.
Whomever provides service must be registered with the Japanese gov't as a service provider. They can only provide service and can NOT warehouse inventory and deliver it from their office. All deliveries must originate outside Japan.
You as a company needs to decide who will provide service / training...but again, this organization can only be a service / training provicer. They can't advertise, warehouse inventory or accept money for the purchase of a device.
Physician must import the device and it must be delivered directly to the physician. BUT, I suggest that your company have an arrangement with a third party importer who acts as a broker. Most physicians do not want to have to make the arrangements.
Your company does not have to have an employee in Japan.
Regarding disposables...I am unclear on what you are asking, but if you want to have an office in Japan warehousing disposables, that is illegal. Unapproved medical devices, including disposables, must be shipped from outside Japan.
There are multiple layers to the Japanese enforcement including local government, PMDA and MHLW. If they take enforcement action against your company, it is very hard to fix in the future...so you have to keep the line clear and clean.
Hope that helps
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Connie Hoy
Vice President, Regulatory Affairs & Compliance Officer
Cutera, Inc
Brisbane CA
United States
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Original Message:
Sent: 04-26-2012 14:43
From: James Talbot
Subject: Physician Import in Japan
I am looking for information on the process for "physician import" in Japan for medical equipment where the MHLW approval process is prohibitive. Basic questions I have:
1. Does physician have to purchase direct from manufacturer?
2. Who services equipment in Japan - manufacturer or can a distributor?
3. Who can provide clinical training - manufacturer, distributor, physician?
4. What paperwork is required to initiate physician import - Import Certificate?
5. Can additional disposables be ordered by anyone other than physician?
6. Is it required to have an employee with a physical presence in Japan?
7. Does customs clearance have to be performed by importing physician?
8. Can warehousing occur at distributor in Japan or must be direct ship to physician?
I am sure there are many other questions - just looking for someone who has been through this process in the US that I might work with. THanks
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James Talbot
Sr. Dir, Quality Systems & Reg Affs
Restoration Robotics
Mountain View CA
United States
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