Accreditation for Foreign Manufacture (MHW Ministerial Ordinance No. 2)

W

wangyang

#1
We are a foreign manufacturer, and i want to know how to get the Accreditation for Manufacture? is a certificate issued? who will issue it?

NOTE: MHW - Japan's Ministry of Health and Welfare -> Now MHLW (Ministry of Health, Labor and Welfare)
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
We need more information to help answer your question.

It sounds like you want to export your product to Japan. Is this correct?

What country are you in?

Can anyone here help with questions about importing medical devices into Japan and anything about japan's "Accreditation for Manufacture" requirements or procedures? My Thanks in advance for any help with this one.
 
A

amanbhai

#4
What kind of medical devices you want to export. We are a thris party inspection/ verification/ testing and certification company.
 

sreenu927

Quite Involved in Discussions
#5
Hi Wangyang,

Being a foreign manufacturer, you need to appoint an Marketing Authorisation Holder (MAH) in Japan, who must have an authorised license/permit to act on your be-half.

You need to send the ISO 13485 cert, Quality manual and other required documents(based on the classification of your medical device) to MAH. He will submit these documents to PMDA and your facility will be registered with PMDA and also the products will be listed.

PMDA won't provide any certificate. Your company name will be indicated in the PMDA register.

If you export high risk devices to Japan, then there is a chance for PMDA to audit your site in China.

Hope this helps!

Also see attached registration flow chart from Emergo and the Japanese QMS regulations guide.

Regards,
Sreenu
 

Attachments

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Reinheitsgebot

#7
Hi all,

Does anyone know what is the validity period of an approved registration for a medium/high risk medical device in Japan, and any information on renewal fees (if applicable)? - thank you.
 
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