Renewal of "Accreditation Certificate of Foreign Medical Device Manufacturer"

SGquality

Quite Involved in Discussions
#1
Need your help urgently -

My organization has a Japan MHLW's "Acreeditation Certificate of Foreign Medical Device Manufacturer" issued in Oct 2008 and valid until Oct 2013. The person who was handling this is no longer with the company and this has fallen on me.

I have no experience - could anyone help me how to renew this Accreditation Certificate ?

Thank you in advance.
 
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sreenu927

Quite Involved in Discussions
#2
Hi SG Quality,

Do you mean that your SG Facility is FMA (i.e., registered with MHLW-Japan)?

For any changes, you need to get the application form from your MAH (Marketing Authorisation Holder) in Japan. Fill the forms (2forms) and send to your MAH, they will complete the change amendment for your FMA.

Regards,
Sreenu
 

SGquality

Quite Involved in Discussions
#3
Re: Renewal of "Acreeditation Certificate of Foreign Medical Device Manufacturer"

Thanks Sreenu.

There were many changes and I do not know about MAH - would it be mentions on the certificate ?

Are the forms that you mentioned avlb on the Internet ?
 
#4
If you have a Japan FMA and you are the OEM manufacturer for an other company who put the device in Japan, it is the responsibility of the other company.

Please clarify your Japan FMA position.
 
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