Japan Medical Device Product Registration

A

AnnieB

#11
Sreenu,
It appears that those lists are of "approved" devices. I'm looking for a Class 1 device. Is there a source for information on Class 1 devices or for foreign manufacturer certifications?
Thanks!
 
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S

sim24kins

#12
View attachment Japan's Accredidation Listing 12-01-10.xls

View attachment Approved Products 2009.pdf

I have this list of accredited companies from the PMDA website converted into as much English as google translator could manage and a listing of the medical devices registered in 2009. Go to the PMDA website in English
http://www.pmda.go.jp/english/index.html
Under the tab "List of Approved Products" you may search registered products for medical devices or drugs by year approved (in English).
 
S

sim24kins

#13
Japanese Market Authorization Holder

Does anyone have advice or a listing on the various MAH's in Japan? We have Class III products and do not want to appoint a Distributor as our MAH. We want an independent Designated Market Authorisation Holder (DMAH) who does not charge invoice percentages and has low fees but are still reliable. We may not need them to do the product registrations, only act as the DMAH.
 
T

TaraMedical

#14
Re: Japanese Market Authorization Holder

Hello sim24kins - I asked my colleagues at UL Japan for help with your question. They do not know of a list, but because each MAH has its own specialty, they may know of DMAHs that provide service for the product type.
 
V

Vlcekad

#15
Dear Collegues,

I are trying to enter Japanese market with intraocular device, EU class IIb.
Our distirbutor in Japan told use, that registering this deivce would take more than 2 years and milions od dollars.

The distributor proposed, that we import lenses as "unapproved devices" which can be do under doctors licence for 1-3 pieces and using [FONT=&quot]Yakkan Shomei . Acording to distributor all premium lenses in Japan are imported as unapproved medical devices and he is importing them like this for many years.

Is it legal to import medical devices to Japan like this? Should we ask for some record of legality?
My concern is how to we deal with complaints and reportable events should they occure?

We have been ask to do quite a similar thing in Mexico. The difeerence wa that our sales rep would have to carry lenses onborard of fligth between Europe and US, then give them to Mexican distributor in US who whou import them to Mexico using his medical licence traveling on land.

Does anyone have experience with these unapproved medical devices imports?
Thanks!


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